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Updated 2017 ICO Guidelines for Diabetic Eye Care

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Text of Updated 2017 ICO Guidelines for Diabetic Eye Care

ICO Guidelines for Diabetic Eye CareUpdated 2017International Council of Ophthalmology | Guidelines for Diabetic Eye Care | Page iCopyright ICO January 2017. Translation and adaption for non-commercial local use is encouraged, but please credit Guidelines for Diabetic Eye CareThe International Council of Ophthalmology (ICO) developed the ICO Guidelines for Diabetic Eye Care to serve a supportive and educational role for ophthalmologists and eye care providers worldwide. They are intended to improve the quality of eye care for patients around the Guidelines address the needs and requirements for the following levels of service: High Resource Settings: Advanced or state-of-the-art screening and management of DR based on current evidence, and clinical trials. Low-/Intermediate Resource Settings: Essential or core to mid-level service for screening and management of DR with consideration for availability and access to care in different Guidelines are designed to inform ophthalmologists about the requirements for the screening and detection of diabetic retinopathy, and the appropriate assessment and management of patients with diabetic retinopathy. The Guidelines also demonstrate the need for ophthalmologists to work with primary care providers and appropriate specialists such as diabetes and diabetic retinopathy a rapidly increasing problem worldwide, it is vital to ensure that ophthalmologists and eye care providers are adequately ICO believes an ethical approach is indispensable, as it is the first step toward quality clinical practices. Download the ICO Code of Ethics at: (PDF 198 KB). The Guidelines are designed to be a working document and will be updated on an ongoing basis. They were first released in December 2013. This document was reviewed, revised, and updated in 2016. The ICO hopes these Guidelines are easy to read, translate, and adapt for local use. The ICO welcomes any feedback, comments, or email us at: 2013 Task Force on Diabetic Eye Care Hugh Taylor, MD, AC, Chairman Susanne Binder, MD Taraprasad Das, MD, FRCS Michel Farah, MD Frederick Ferris, MD Pascale Massin, MD, PhD, MBA Wanjiku Mathenge, MD, PhD, MBChB Serge Resnikoff, MD, PhD Bruce E. Spivey, MD, MS, MEd Juan Verdaguer, MD Tien Yin Wong, MD, PhD Peiquan Zhao, MD2016 Diabetic Eye Care Committee Tien Yin Wong, MBBS, PhD (Singapore), Chairman Lloyd Paul Aiello, MD, PhD (USA) Frederick Ferris, MD (USA) Neeru Gupta, MD, PhD, MBA (Canada) Ryo Kawasaki, MD, MPH, PhD (Japan) Van Lansingh, MD, PhD (Mexico) Mauricio Maia, MD, PhD (Brazil) Wanjiku Mathenge, MD, PhD, MBChB (Rwanda) Sunil Moreker, MBBS (India) Mahi Muqit, FRCOphth, PhD (UK) Serge Resnikoff, MD, PhD (Switzerland) Paisan Ruamviboonsuk, MD (Thailand) Jennifer Sun, MD, MPH (USA) Hugh Taylor, MD, AC (Australia) Juan Verdaguer, MD (Chile) Peiquan Zhao, MD (China)International Council of Ophthalmology | Guidelines for Diabetic Eye Care | Page iiCopyright ICO January 2017. Translation and adaption for non-commercial local use is encouraged, but please credit Epidemiology of Diabetic Retinopathy Classification of Diabetic Retinopathy Nonproliferative Diabetic Retinopathy (NPDR) Proliferative Diabetic Retinopathy (PDR) Diabetic Macular Edema (DME) Table 1. International Classification of Diabetic Retinopathy and Diabetic Macular Edema Table 2a. Re-examination and Referral Recommendations Based on Simplified Classification of Diabetic Retinopathy and Diabetic Macular Edema for High Resource Settings Table 2b. Re-examination and Referral Recommendations Based on Simplified Classification of Diabetic Retinopathy and Diabetic Macular Edema for Low-/Intermediate Resource SettingsScreening Guidelines Screening Guidelines Referral GuidelinesDetailed Ophthalmic Assessment of Diabetic Initial Patient Assessment Patient History (Key Elements) Initial Physical Exam (Key Elements) Fundus Examination Assessment Methods Follow-up Examination of Patients with Diabetic Retinopathy Follow-up History Follow-up Physical Exam Ancillary Tests (High Resource Settings) Patient Education Table 3a. Follow-up Schedule and Management based on Diabetic Retinopathy Severity for High Resource Settings Table 3b. Follow-up Schedule and Management based on Diabetic Retinopathy Severity for Low-/Intermediate Resource Settings Treatment of Diabetic High Resource Settings Low-/Intermediate Resource Settings Panretinal Photocoagulation (PRP) Pre-treatment Discussion with Patients Lenses for PRP Table 4. Laser Spot Size Adjustment Required for Different Lenses Contact Technique for PRP Table 5. The burn characteristics for panretinal photocoagulation111112233344455666667788 88899Table of ContentsInternational Council of Ophthalmology | Guidelines for Diabetic Eye Care | Page iiiCopyright ICO January 2017. Translation and adaption for non-commercial local use is encouraged, but please credit A. Technique for PRP. 13Annex B. Recommended Practice for Intravitreal Injection. 15Annex Table 1. Features of Diabetic Retinopathy (also see the photographs continued in the annex). 16Annex Table 2. Features of Proliferative Diabetic Retinopathy. 17Annex Table 3. Available Assessment Instruments and Their Advantages and Disadvantages. 17Annex Flowchart 1. Screening for Diabetic Retinopathy. 19Annex Flowchart 2. Treatment decision tree of DME based on Central-Involvementand Vision. 19Annex Flowchart 3. Anti-VEGF treatment decision tree based on the re-treatment and follow-up schedule . 20Figure 1. Mild nonproliferative diabetic retinopathy with microaneurysms . 21Figure 2. Moderate nonproliferative diabetic retinopathy with hemorrhages, hard exudates and microaneurysms. 21Figure 3. Moderate nonproliferative diabetic retinopathy with moderate macular edema, with hard exudates approaching the center of the macula. 22Figure 4. Moderate nonproliferative diabetic retinopathy with no diabetic macular edema. 22Figure 5. Moderate nonproliferative diabetic retinopathy with mild diabetic macular edema. 23Figure 6. Moderate nonproliferative diabetic retinopathy with severe macular edema. 2356789Treatment for Diabetic Macular Edema (DME) High Resource Settings Low-/Intermediate Resource Settings Laser Technique for Macular Edema Table 6. Modified-ETDRS and the Mild Macular Grid Laser Photocoagulation Techniques Indications for VitrectomyManagement of Diabetic Retinopathy in Special Pregnancy Management of CataractList of Suggested Indicators for Evaluation of DR ProgramsEquipmentInternational Council of Ophthalmology | Guidelines for Diabetic Eye Care | Page ivCopyright ICO January 2017. Translation and adaption for non-commercial local use is encouraged, but please credit 7a. Moderate nonproliferative diabetic retinopathy with moderate macular edema. 24Figure 7b. Fundus Fluorescein Angiogram showing moderate nonproliferative diabetic retinopathy with moderate macular edema. 24Figure 8. Severe nonproliferative diabetic retinopathy with severe diabetic macular edema. 25Figure 9. Severe nonproliferative diabetic retinopathy with severe diabetic macular edema. 25Figure 10. Severe nonproliferative diabetic retinopathy with venous loop. 26Figure 11. Severe nonproliferative diabetic retinopathy with intra retinal microvascular abnormality (IRMA). 26Figure 12. Proliferative diabetic retinopathy with venous beading, new vessels elsewhere (NVE) and severe diabetic macular edema. 27Figure 13. High risk proliferative diabetic retinopathy with new vessels on the disc. 27Figure 14a. High risk proliferative diabetic retinopathy. Preretinal hemorrhage before with new vessels on the disc. 28Figure 14b. High risk proliferative diabetic retinopathy, with new panretinal photocoagulation (PRP) scars. 28Figure 15a. Proliferative diabetic retinopathy. New vessels on the disc and elsewhere. 29Figure 15b. Proliferative diabetic retinopathy. New vessels on the disc and elsewhere on fundus fluorescein angiogram. 29Figure 16a. Diabetic macular edema with panretinal photocoagulation (PRP) (right eye). 30Figure 16b. Diabetic macular edema with panretinal photocoagulation (PRP) (left eye). 30Figure 17a. Persistent diabetic macular edema after focal laser treatment. 31Figure 17b. Persistent diabetic macular edema after focal laser treatment on fundus fluorescein angiogram. 31Figure 18a. Proliferative diabetic retinopathy with preretinal hemorrhage. 32Figure 18b. Proliferative diabetic retinopathy with preretinal hemorrhage on fundus fluorescein angiogram. 32Figure 19. Panretinal (PRP) photocoagulation. First session: inferior retina (laser scars). Second session: superior retina (fresh burns). Third session will be needed to complete PRP. 33Figure 20. Optical coherence tomography (OCT) showing diabetic macular edema with thickened retina and intra-retinal cystic changes 33International Council of Ophthalmology | Guidelines for Diabetic Eye Care | Page 1Copyright ICO January 2017. Translation and adaption for non-commercial local use is encouraged, but please credit IntroductionDiabetes mellitus (DM) is a global epidemic with significant morbidity. Diabetic retinopathy (DR) is the specific microvascular complication of DM and affects 1 in 3 persons with DM. DR remains a leading cause of vision loss in working adult populations. Patients with severe levels of DR are reported to have poorer quality of life and reduced levels of physical, emotional, and social well-being, and they utilize more health care studies and clinical trials have shown that optimal control of blood glucose, blood pressure, and blood lipids can reduce the risk of developing retinopathy and slow its progression. Timely treatment with laser photocoagulation, and increasingly, the appropriate use of intraocular administration of vascular endothelial growth factor (VEGF) inhibitors can prevent visual loss in vision-threatening retinopathy, particularly diabetic macular edema (DME). Since visual loss may not be present in the earlier stages of retinopathy, regular screening of persons with diabetes is essential to enable early Epidemiology of Diabetic Retinopathy In many countries, DR is the most frequent cause of preventable blindness in working-aged adults. A Global meta-analysis study reported that 1 in 3 ( ) had any form of DR in the US, Australia, Europe and Asia. It is also noted that 1 in 10 ( ) had vision threatening DR (VTDR) , PDR and/or DME. In the 2010 world diabetes population, more than 92 million adults had any form of DR, 17 million had PDR, 20 million had DME and 28 million had VTDR. DR develops with time and is associated with poor control of blood sugar, blood pressure, and blood lipids. The longer someone has had DM, and the poorer their control, the higher their risk of developing DR. Good control reduces the annual incidence of developing DR and extends life by reducing risk of cardiovascular diseases. However, good control does not necessarily reduce the lifetime risk of developing DR, so everyone with DM is at overall prevalence of DR in a community is also influenced by the number of people diagnosed with early DM: In high resource settings with good health care systems, more people with early DM will have been diagnosed through screening. The prevalence of DR in people with newly diagnosed DM will be low, resulting in a lower overall prevalence of DR. In low-/intermediate resource settings with less advanced health care systems, fewer people with early DM will have been diagnosed because early stage of DM is asymptomatic. People may be diagnosed with diabetes only when symptomatic or complications have occurred. Thus, the prevalence of DR in people with newly diagnosed DM will be high, resulting in a somewhat higher overall prevalence of Classification of Diabetic Retinopathy The classic retinal lesions of DR include microaneurysms, hemorrhages, venous beading (venous caliber changes consisting of alternating areas of venous dilation and constriction), intraretinal microvascular abnormalities, hard exudates (lipid deposits), cotton-wool spots (ischemic retina leading to accumulations of axoplasmic debris within adjacent bundles of ganglion cell axons), and retinal neovascularization (Annex Figures). These findings can be utilized to classify eyes as having one of two phases of Nonproliferative Diabetic Retinopathy (NPDR)Eyes with nonproliferative DR (NPDR) have not yet developed neovascularization, but may have any of the other classic DR lesions. Eyes progress from having no DR through a spectrum of DR severity that includes mild, moderate and severe NPDR. Correct identification of the DR severity level of an eye allows a prediction of risk of DR progression, visual loss, and determination of appropriate treatment recommendations including follow-up interval. Annex Table 1 details the signs associated with Proliferative Diabetic Retinopathy (PDR)Proliferative diabetic retinopathy (PDR) is the most advanced stage of DR and represents an angiogenic response of the retina to extensive ischemia from capillary closure. Retinal neovascularization is typically characterized as being new vessels on the disc (NVD) or new vessels elsewhere (NVE) along the vascular arcades. NVE often occur at the interface between perfused and nonperfused areas of retina. Annex Table 2 includes the signs associated with stages of DR, from nonproliferative to proliferative DR, can be categorized using the simple International Classification of DR scale shown in Table 1. International Council of Ophthalmology | Guidelines for Diabetic Eye Care | Page 2Copyright ICO January 2017. Translation and adaption for non-commercial local use is encouraged, but please credit Diabetic Macular Edema (DME)Diabetic macular edema (DME) is an additional important complication that is assessed separately from the stages of retinopathy, as it can be found in eyes at any DR severity level and can run an independent course. Currently, diabetic eyes are generally classified as having no DME, noncentral-involved DME, or central-involved DME. The determination of DME severity based on these 3 categories will determine the need for treatment and follow-up recommendations. The stages of DR can be classified using the International Classification of DR Scale shown in Table 1. Based on this Classification, referral decision can be used in high resource settings (Table 2a), and low-/intermediate settings (Table 2b). It is important to remember that advanced stages of DR and DME may be present even in patients who are not experiencing visual symptoms. An online self-directed course on the grading of diabetic retinopathy is available at: 1: International Classification of Diabetic Retinopathy and Diabetic Macular EdemaDiabetic RetinopathyFindings Observable on Dilated OphthalmoscopyNo apparent DRNo abnormalitiesMild nonproliferative DRMicroaneurysms onlyModerate nonproliferative DRMicroaneurysms and other signs ( , dot and blot hemorrhages, hard exudates, cotton wool spots), but less than severe nonproliferative DRSevere nonproliferative DRModerate nonproliferative DR with any of the following: Intraretinal hemorrhages ( 20 in each quadrant); Definite venous beading (in 2 quadrants); Intraretinal microvascular abnormalities (in 1 quadrant); and no signs of proliferative retinopathyProliferative DRSevere nonproliferative DR and 1 or more of the following: Neovascularization Vitreous/preretinal hemorrhageDiabetic Macular EdemaFindings Observable on DilatedOphthalmoscopy#No DME No retinal thickening or hard exudates in the maculaNoncentral-involved DMERetinal thickening in the macula that does not involve the central subfield zone that is 1mm in diameterCentral-involved DMERetinal thickening in the macula that does involve the central subfield zone that is 1mm in diameter# Hard exudates are a sign of current or previous macular edema. DME is defined as retinal thickening, and this requires a three-dimensional assessment that is best performed by a dilated examination using slit-lamp biomicroscopy and/or stereo fundus photography. International Council of Ophthalmology | Guidelines for Diabetic Eye Care | Page 3Copyright ICO January 2017. Translation and adaption for non-commercial local use is encouraged, but please credit 2a. Re-examination and Referral Recommendations Based on International Classification of Diabetic Retinopathy* and Diabetic Macular Edema for High Resource Retinopathy (DR)ClassificationRe-examination Or next screening scheduleReferral to OphthalmologistNo apparent DR, mild nonproliferative DR and no DMERe-examination in 1-2 yearReferral not requiredMild nonproliferative DR6-12 monthsReferral not requiredModerate nonproliferative DR3-6 monthsReferral requiredSevere nonproliferative DR< 3-monthsReferral requiredPDR< 1 monthReferral requiredDiabetic Macular Edema (DME)ClassificationRe-examination Or next screening scheduleReferral to OphthalmologistNoncentral-involved DME3 monthsReferral required Central-involved DME1 monthReferral required* In cases where diabetes is 2b. Re-examination and Referral Recommendations Based on Simplified Classification of Diabetic Retinopathy* and Diabetic Macular Edema for Low-/Intermediate Resource Retinopathy (DR)ClassificationRe-examination Or next screening scheduleReferral to OphthalmologistNo apparent DR, mild nonproliferative DR and no DMERe-examination in 1-2 yearReferral not requiredMild nonproliferative DR1-2 yearReferral not requiredModerate nonproliferative DR6-12 monthsReferral requiredSevere nonproliferative DR< 3 monthsReferral requiredPDR< 1 monthReferral requiredDiabetic Macular Edema (DME)ClassificationRe-examination Or next screening scheduleReferral to OphthalmologistNoncentral-involved DME3 monthsReferral not required(referral recommended if laser resources available) Central-involved DME1 monthReferral required* In cases where diabetes is Screening Screening GuidelinesScreening for DR is an important aspect of DM management worldwide. Even if an adequate number of ophthalmologists are available, using ophthalmologists or retinal subspecialists to screen every person with DM is an inefficient use of screening exam could include a complete ophthalmic examination with refracted visual acuity and state-of-the-art retinal imaging. However, in a low-/intermediate resource settings, the minimum examination components to assure appropriate referral should include a screening visual acuity exam and retinal examination adequate for DR classification. Vision should be tested prior to pupil dilation. Annex Flowchart 1 shows an example of the screening process for Council of Ophthalmology | Guidelines for Diabetic Eye Care | Page 4Copyright ICO January 2017. Translation and adaption for non-commercial local use is encouraged, but please credit screening vision exam should be completed by trained personnel in any of the following ways, depending on resources: Refracted visual acuity examination using a 3- or 4-meter visual acuity lane and a high contrast visual acuity chart. Presenting visual acuity examination using a near or distance eye chart and a pin-hole option if visual acuity is reduced. Presenting visual acuity examination using a 6/12 (20/40) equivalent handheld chart consisting of at least 5 standard letters or symbols and a pin-hole option if visual acuity is retinal examination may be accomplished in the following ways: Direct or indirect ophthalmoscopy or slit-lamp biomicroscopic examination of the retina. Retinal (fundus) photography (including any of the following: widefield to 30o; mono- or stereo-; dilated or undilated).This could be done with or without accompanying optical coherence tomography (OCT) scanning. This could also include telemedicine approaches. (Annex Table 3) For the retinal examination, a medical degree may not be necessary, but the examiner must be well trained to perform ophthalmoscopy or retinal photography and be able to assess the severity of adequate information from the visual acuity and retinal examinations, one can decide on an appropriate management plan, as outlined in Table 2a and Table 2b. The plan may be modified based on individual patient with less than adequate retinal assessment should be referred to an ophthalmologist unless it is obvious that there is no DR, or at most, only mild nonproliferative DR ( , microaneurysms only). In addition, persons with unexplained visual-acuity loss should be part of a screening exam, persons with diabetes should be asked about their diabetes control, including blood glucose, blood pressure, and serum lipids. In addition, women should be asked if they are or could be pregnant. Inadequate control and pregnancy may require further appropriate medical Referral GuidelinesMinimum referral guidelines are as follows:i. Visual acuity below 6/12 (20/40) or symptomatic vision complaintsii. If DR can be classified according to the simplified International Classification of DR (Table 1), they should be referred accordingly (Table 2a and Table 2b). iii. If visual acuity or retinal examination cannot be obtained at the screening examination: refer to Detailed Ophthalmic Assessment of Diabetic Initial Patient AssessmentDetailed patient assessment should include a complete ophthalmic examination, including visual acuity and the identification and grading of severity of DR and presence of DME for each eye. The patient assessment should also include the taking of a patient history focused on diabetes and its Patient History (Key Elements) Duration of diabetes Past glycemic control (hemoglobin A1c) Medications (especially insulin oral hypoglycemics, antihypertensives, and lipid-lowering drugs) Systemic history ( , renal disease, systemic hypertension, serum lipid levels, pregnancy) Ocular history International Council of Ophthalmology | Guidelines for Diabetic Eye Care | Page 5Copyright ICO January 2017. Translation and adaption for non-commercial local use is encouraged, but please credit Initial Physical Exam (Key Elements) Visual acuity Measurement of intraocular pressure (IOP) Gonioscopy when indicated ( , when neovascularization of the iris is seen or in eyes with increased IOP) Slit-lamp biomicroscopy Fundus examination Fundus Examination Assessment Methods Currently, the two most sensitive methods for detecting DR are retinal photography and slit-lamp biomicroscopy through dilated pupils. Both depend on interpretation by trained eye health professionals. Other methods are listed in Annex Table photography has the advantage of creating a permanent record, and for that reason, it is the preferred method for retinopathy assessment. However, well-trained observers can identify DR without photography and there are many situations in which that would be the examination of use of all instruments requires training and competence but more skill is needed for indirect ophthalmoscopy and slit-lamp biomicroscopy than for fundus photography. Newer, semi-automatic nonmydriatic fundus cameras can be very easy to use. Media opacities will lead to image/view degradation and all photographs/images must be reviewed by trained personnel. International Council of Ophthalmology | Guidelines for Diabetic Eye Care | Page 6Copyright ICO January 2017. Translation and adaption for non-commercial local use is encouraged, but please credit Follow-up Examination of Patients with Diabetic Retinopathy In general, the follow-up history and examination should be is similar to the initial examination. The assessment of visual symptoms, visual acuity, measurement of IOP, and fundus examination are Follow-up History Visual symptoms Glycemic status (hemoglobin A1c) Systemic status ( , pregnancy, blood pressure, serum lipid levels, renal status) Follow-up Physical Exam Visual Acuity Measurement of IOP Gonioscopy when indicated Slit-lamp biomicroscopy Fundus examination Ancillary Tests (High Resource Settings) OCT is the most sensitive method to identify DME. OCT can provide quantitative assessment of DME to determine the severity of DME. Retinal map scan is useful in locating the area with retinal thickening; single scan is useful in detailing the types of DME as diffuse, cystic changes, sub-retinal fluid/detachment, and vitreoretinal traction. Fundus photography is a useful way of recording the disease activity. It is useful in determining detailed severity of the disease. Fluorescein angiography is not required to diagnose DR, proliferative DR or DME, all of which are diagnosed by means of fundus examination. Fluorescein angiography can be used as a guide to evaluate retinal non-perfusion area, presence of retinal neovascularization, and microaneurysms or macular capillary non-perfusion in Patient Education Discuss results or exam and implications. Encourage patients with DM but without DR to have annual screening eye exams. Inform patients that effective treatment for DR depends on timely intervention, despite good vision and no ocular symptoms. Educate patients about the importance of maintaining near-normal glucose levels, near-normal blood pressure and to control serum lipid levels. Communicate with the general physician ( , family physician, internist, or endocrinologist) regarding eye findings. Provide patients whose conditions fail to respond to surgery and for whom treatment is unavailable with proper professional support ( , offer referrals for counseling, rehabilitative, or social services as appropriate). Refer patients with reduced visual function for vision rehabilitation and social services. Refer patients who have underwent treatment, including PRP and surgery, on timely Council of Ophthalmology | Guidelines for Diabetic Eye Care | Page 7Copyright ICO January 2017. Translation and adaption for non-commercial local use is encouraged, but please credit 3a. Follow-up Schedule and Management based on Diabetic Retinopathy Severity for High Resource Settings. Diabetic Retinopathy SeverityFollow-up Schedule for management by ophthalmologistsNo apparent DR Re-examination in 1-2 years; This may not require re-examination by an ophthalmologistMild nonproliferative DR 6-12 months; This may not require re-examination by an ophthalmologistModerate nonproliferative DR 3-6 monthSevere nonproliferative DR<3 months; Consider early pan-retinal DR <1 month; Consider pan-retinal (Treated) PDR6-12 monthsDiabetic Macular Edema severityFollow-up Schedule for management by ophthalmologistsNoncentral-involved DME3-6 month; Consider focal laser photocoagulationCentral-involved DME1-3 month; Consider focal laser photocoagulation or anti- VEGF therapyStable DME3-6 monthTable 3b. Follow-up Schedule and Management based on Diabetic Retinopathy Severity for Low-/Intermediate Resource Settings. Diabetic Retinopathy SeverityFollow-up Schedule for management by ophthalmologistsNo apparent DR Re-examination in 1-2 years; This may not require re-examination by an ophthalmologistMild nonproliferative DR1-2 years; This may not require re-examination by an ophthalmologistModerate nonproliferative DR 6-12 months Severe nonproliferative DR<3 monthProliferative DR <1 month; Consider pan-retinal (Treated) PDR6-12 monthDiabetic Macular Edema severityFollow-up Schedule for management by ophthalmologistsNoncentral-involved DME3-6 monthCentral-involved DME1-3 month; Consider focal laser photocoagulation or anti- VEGF therapyStable DME3-6 monthInternational Council of Ophthalmology | Guidelines for Diabetic Eye Care | Page 8Copyright ICO January 2017. Translation and adaption for non-commercial local use is encouraged, but please credit Treatment of Diabetic High Resource Settingsi. Optimize medical treatment: Improve glycemic control if HbA1c > 58 mmol/mol (> ) as well as associated sys-temic hypertension or No DR, Mild or Moderate NPDR: Follow at recommended intervals with dilated eye examinations and retinal imag-ing as needed. Treat DME as needed (see below). iii. Severe NPDR: Follow closely for development of PDR. Consider early panretinal photocoagulation for patients at high risk of progression to PDR or poor compliance with follow-up. There are benefits of early panretinal photocoagu-lation at the severe NPDR stage for patients with type 2 diabetes. Other factors, such as poor compliance with follow-up, impending cataract extraction or pregnancy, and status of fellow eye will also help in determining the timing of the panretinal PDR: Treat with panretinal photocoagulation (PRP). There is increasing evidence from clinical trials demonstrating anti-VEGF injections (ranibizumab) as a safe and effective treatment of PDR through at least 2 years and that other intravit-real anti-VEGF agents ( aflibercept and bevacizumab) are also highly effective against retinal Low-Intermediate Resource Settingsi. Generally similar to above. PRP is preferred for the treatment of severe NPDR and PDR. Panretinal Photocoagulation (PRP) Pre-treatment Discussion with Patients Patients usually need numerous follow-up visits and may require supplementary laser treatment. PRP reduces the risk of visual loss and blindness. Although laser treatment is effective, some patients may still develop vitreous hemorrhage. The hemorrhage is caused by the diabetes and not by the laser; it may mean the patient needs more laser treatment. Laser treatment often reduces peripheral and night vision; treatment may moderately reduce central vision. The conventional long pulse 100ms PRP treatments are associated with loss of vision. The recommended short pulse 20-30ms PRP treatments are less likely to cause this Lenses for PRP The three-mirror Goldmann contact lens has a central opening for treating the posterior pole, and side mirrors for treating the mid peripheral and peripheral retina. Disadvantages: small field of view, which requires continual manipulation of the lens to complete treatment. Spot size is set at 500 m. Newer wide-angle contact lenses are often used. Although the image is inverted, there is a large field of view allowing for many burns with the field while easily maintaining orientation to the disc and macula. The optics of these wide-angle lenses will affect the laser spot size on the retina (Table 4). Wide-angle indirect ophthalmoscopy lenses provide an inverted image, but show a large field of view and a magnification of the spot in the retina (Table 4). Scatter treatment can be applied to a large area of retina in a single image, and it is easy to visualize the disk and the 4: Laser Spot Size Adjustment Required for Different Lenses ContactLensField of VisionAxial magnificationSpot magnificationSpot Size Setting for ~500 umMainster Wide-Field125 mVolk TransEquator120-125 mVolk Quad/Aspheric130-135 to 300 mMainster PRP 165160 to 300 mInternational Council of Ophthalmology | Guidelines for Diabetic Eye Care | Page 9Copyright ICO January 2017. Translation and adaption for non-commercial local use is encouraged, but please credit Technique for PRP (refer to Annex A for more details)i. The pupil should be fully dilated and topical anesthesia is used. Retrobulbar or subtenons anesthesia to reduce pain and decrease eye motion can be employed as Typical initial settings on the Argon laser would be 500 m spot size, a second exposure and 250-270 mw power. The power is gradually increased until a whitish reaction is obtained on the retina. The lesions are placed 1 burn width apart. (Table 5)iii. A total of 1600-3000 burns are placed in 1 or more sittings, carefully avoiding the macular area and any areas of tractional elevation of the retina. The burns are placed 2 to 3 disc diameters away from the center of the macula and 1 disc diameter away from the disc, usually outside the arcades and extended peripherally up to the equator and Laser treatment should not be applied over major retinal veins, preretinal hemorrhages, darkly pigmented chorioretinal scars, or within 1 DD (200-300 m) of center of macula, so as to avoid risk of hemorrhage or large Other considerations: Additional photocoagulation is needed if there is evidence of worsening of proliferative DR. Add laser burns in between scars of initial treatment further peripherally and also at the posterior pole, sparing the area within 500-1500 m from the center of the macula. Favor quadrants with active new vessels or areas with intraretinal microvascular abnormalities where scars are more widely spaced and areas of severe ischemia not previously treated, such as the temporal part of the posterior pole. There is increasing use of multi-spot laser 5. The burn characteristics for panretinal photocoagulation:Size (on retina):500 to seconds or seconds can be considered for use in High Resource Settings (in certain laser machines, where applicable). Intensitymild white ( 2+ to 3+ burns)DistributionMild and moderate PDR:Edges 1 burn width apartSevere PDR: Edges to burn width apartNumber of sessions/sittings1 to 3Nasal proximity to diskNo closer than 500 mTemporal proximity tocenterNo closer than 3000 mSuperior/inferior limitNo further posterior than 1 burn within the temporal arcadesExtentArcades (~3000 m from the macular center) to at least the equatorInternational Council of Ophthalmology | Guidelines for Diabetic Eye Care | Page 10Copyright ICO January 2017. Translation and adaption for non-commercial local use is encouraged, but please credit number of burns1200 1600 There may be instances where 1200 burns are not possible such as the development of vitreous hemorrhage or inability to complete a sitting precluding completion of the PRP session. Similarly, there may be clinical situations in which more than 1600 burns are needed such as initial difficulty with laser uptake due to media is a guide for 20ms PRP and 100ms PRP:Mild PDR: 20ms PRP ETDRS laser 100ms2400-3500 burns 1200-1800 burnsModerate PDR: 20ms PRP ETDRS laser 100ms4000-5000 burns 2000-2500 burnsSevere PDR: 20ms PRP ETDRS laser 100ms5500-6000 burns 2000-2500WavelengthGreen or yellow (red can be used if vitreous hemorrhage is present)5. Treatment for Diabetic Macular Edema (DME) High Resource Settingsi. Optimize medical treatment: Improve glycemic control if HbA1c > 58 mmol/mol (> ) as well as associated systemic hypertension or DME without central involvement: May observe until there is progression to central involvement, or consider focal laser to leaking microaneurysms if thickening is threatening the fovea (Annex Flowchart 2). No treatment is applied to lesions closer than 300-500 m from the center of the Central-involved DME and good visual acuity (better than 6/9 or 20/30): 3 treatment options being evaluated in an ongoing clinical trial: (1) careful follow-up with anti-VEGF treatment only for worsening DME; (2) intravitreal anti- VEGF injections; or (3) laser photocoagulation with anti-VEGF, if Central-involved DME and associated vision loss (6/9 or 20/30 or worse): intravitreal anti-VEGF treatment ( , with ranibizumab [Lucentis] or , bevacizumab [Avastin] , or aflibercept [Eylea]) 2mg therapy). Treatment with aflibercept may provide the best visual outcomes over 1 year, especially in eyes with baseline visual acuity of 6/15 (20/50) or worse. However, by 2 years of therapy, ranibizumab-treated eyes achieve similar visual results to those given aflibercept. Consideration should be given to monthly injections followed by treatment interruption and re-initiation based on visual stability and OCT (Annex Flowchart 3). Patients should be monitored almost monthly with OCT to consider the need for treatment. Typically, the number of injections is 8-10 in the first year, 2 or 3 during the second year, 1 to 2 during the third year, and 0 to 1 in the fourth and fifth years of treatment. For eyes with persistent retinal thickening despite anti-VEGF therapy, consider laser treatment after 24 weeks. Treatment with intravitreal triamcinolone may also be considered, especially in pseudophakic eyes. Injections are given to 4 mm behind the limbus in the inferotemporal quadrant under topical anesthesia using a sterile technique (see Annex B for details).v. DME associated with proliferative DR: monotherapy with intravitreal anti-VEGF therapy should be considered with re-evaluation for need for PRP versus continued anti-VEGF once the DME Vitreomacular traction or epiretinal membrane on OCT: pars plana vitrectomy may be Low-/Intermediate Resource Settingsi. Generally similar to above. Focal laser is preferred if intravitreal injection of anti-VEGF agents are not available or if monthly follow up is not possible. Bevacizumab (Avastin) is an appropriate alternative to ranibizumab (Lucentis) or aflibercept (Eylea). Laser can be applied earlier to areas of persistent retinal thickening in eyes unresponsive to anti-VEGF treatment.(Continued) Table 5. The burn characteristics for panretinal photocoagulation:International Council of Ophthalmology | Guidelines for Diabetic Eye Care | Page 11Copyright ICO January 2017. Translation and adaption for non-commercial local use is encouraged, but please credit Laser Technique for Diabetic Macular Edemai. Modified ETDRS guidelines recommends focal laser treatment of microaneurysms and grid treatment of areas of diffuse leakage and focal nonperfusion within 2DD of center of the macula. There is increasing evidence that laser for microaneurysms is not recommended and multiple re-treatments of microaneurysms can lead to heavy retinal laser burns and future laser scars and central scotomas. (Table 6)ii. Laser parameters used are 50-100 m spot size, 120-150 mW energy and very light gray intensity of the burn. Care is taken to demarcate and avoid the foveal avascular If DME is associated with large areas of macular ischemia, only the areas of retinal thickening are treated. Table 6. Modified-ETDRS and the Mild Macular Grid Laser Photocoagulation TechniquesFocal direct laser treatmentDirectly treat all leaking microaneurysms in areas of retinal thickening between 500 and 3000 m from the center of the macula (but not within 500 m of disc). Change in microaneurysms color with direct treatment is not required, but at least a mild gray-white burn should be evident beneath all microaneurysms. Burn size50-100 mBurn to secWavelengthGreen to yellow wavelengthsGrid laser treatmentApplied to all areas with diffuse leakage or non-perfusion area. Treat the area 500 to 3000 m superiorly, nasally and inferiorly from the center of the macula, and 500 to 3500 m temporally from macular center. No burns are placed within 500 m of disc. Aim barely visible (light gray) laser burn and each burn should be at least two visible burn widths size50-100 mBurn to secWavelengthGreen to yellow wavelengths6 Indications for Vitrectomyi. Severe vitreous hemorrhage of 1 3 months duration or longer that does not clear spontaneously. Earlier intervention may be warranted in low-/intermediate resource settings as the underlying PDR disease may have been previously untreated and highly advanced. In these settings it may be reasonable to perform vitrectomy in eyes with vitreous hemorrhage of 4 -6 weeks duration that has not cleared Advanced active proliferative DR that persists despite extensive PRP. Surgery is reasonable in eyes with recurrent episodes of vitreous haemorrhage from PDR due to persistent vessels despite PRP or mechanical traction on Traction macular detachment of recent onset. Fovea-threatening or progressive macula-involving traction detachments benefit from surgical Combined traction-rhegmatogenous retinal Tractional macular edema or epiretinal membrane involving the macula. This includes vitreomacular Management of Diabetic Retinopathy in Special PregnancyProgression of DR is a significant risk in pregnancy. The following are recommendations:i. Patients with pre-existing diabetes planning pregnancy should be informed on the need for assessment of DR before and during pregnancy. Pregnant women with pre-existing diabetes should be offered retinal assessment following their first antenatal clinic appointment and again at 28 weeks if the first assessment is normal. If any DR is present, additional retinal assessment should be performed at 16-20 Diabetic retinopathy should not be considered a contraindication to rapid optimisation of glycaemic control in women who present with a high HbA1c in early pregnancy but retinal assessment is Diabetic retinopathy should not be considered a contraindication to vaginal Council of Ophthalmology | Guidelines for Diabetic Eye Care | Page 12Copyright ICO January 2017. Translation and adaption for non-commercial local use is encouraged, but please credit Management of CataractDR progresses faster after cataract surgery, so principles of management are as follows:i. Mild cataract - carefully assess DR status. Patients without vision loss with clear fundus view may not require cataract Moderate cataract - carefully assess DR status. Attempt to treat any severe NPDR with laser PRP, and/or DME with focal/grid laser or anti-VEGF therapy, before cataract surgery. Once DR/DME is stable, consider cataract surgery to improve Severe to advanced cataract with poor fundus view - if DR status cannot be adequately assessed, consider early cataract surgery followed by assessment and treatment as necessary. If DME is present, consider anti-VEGF before surgery, at the time of surgery, or after surgery if DME is discovered when the media is List of Suggested Indicators for Evaluation of DR Programsi. Prevalence of diabetic retinopathy and DME related blindness and visual impairment*ii. Proportion of blindness and visual impairment due to DR*iii. Last eye examination for DR among known persons with diabetes (males/females)* Never had eye examination for DR 0 12 months ago 13 24 months ago >24 months ago Could be simplified as: never/0-12 months ago/>12 months agoiv. Number of patients who were examined for DR during last yearv. Number of patients who received laser and/or anti-VEGF treatment/surgery during last yearvi. Number of patients that receive first PRP laser for screen positive/newly-diagnosed PDRvii. Tool for the Assessment of Diabetic Retinopathy and Diabetes Management Systems (WHO-TADDS)This absolute number could be used to define ratios such as:viii. Number of patients who received laser and/or anti-VEGF treatments per million general population per year. [equivalent to Cataract Surgical Rate (CSR)]ix. Number of patients who received laser and/or anti-VEGF treatments per number of patients with diabetes in a given area (hospital catchment area, health district, region, country) Numerator: number of laser and/or anti-VEGF treatments during the last year Denominator: number of patients with diabetes (population x prevalence of DM; source: IDF Atlas)x. Number of patients who received laser and/or anti-VEGF treatments per number of persons with vision- threatening DR in a given area (hospital catchment area, health district, region, country) Numerator: number of laser and/or anti-VEGF treatments during the last year Denominator: number of patients with vision-threatening DR (population x prevalence of DM x ; source: IDF Atlas)* Data available from RAAB : Estimated average prevalence of vision-threatening DR. International Council of Ophthalmology | Guidelines for Diabetic Eye Care | Page 13Copyright ICO January 2017. Translation and adaption for non-commercial local use is encouraged, but please credit EquipmentCore/essential: for screening, initial assessment, and follow-up: Nonmydriatic retinal (fundus) camera (recommended for screening). Indirect ophthalmoscopy (optional for screening, panoramic view, low magnification). Pupils must be dilated. Noncontact biconvex indirect lenses used with the slit lamp (90 D for screening, 78 D for more magnification). Direct ophthalmoscopy (optional for screening). Pupils must be dilated. Three-mirror contact lens used with slit lamp for stereoscopic and high-resolution images of the macula (evaluation of macular edema). Pupils must be dilated. Slit-lamp biomicroscope. Laser equipment: Currently, the most used lasers are (1) The green laser 532 nm, frequency-doubled Nd:YAG or 514 nm argon laser. The 810 nm infrared laser, or diode laser this causes deeper burns with a higher rate of patient discomfort, but tend to be cheaper, is effective, and requires less maintenance. Recommended in tertiary/reference centers: OCT Fluorescein angiography Mydriatic retinal photography (large field conventional fundus camera) Green lasers are the most used, but the pattern-laser method, with a predetermined multispot treatment cascade and the 577 nm yellow laser can be used in selected casesIAPB Standard List of EquipmentThe online version of the International Agency for the Prevention of Blindness (IAPB) Standard List provides information for eye health providers on a carefully evaluated range of eye care technologies, supplies, and training resources suitable for use in settings with limited more information and to get access, please register and log on at registered users have access to the IAPB Standard List catalogue. Please be aware the registration process may take a few days for approvals to be A. Technique for PRP1. If there is a significant anxiety and pain with slit-lamp PRP, then patient can undergo indirect PRP in theatre using subtenon s block. The eye movements are restricted by retrobulbar/subtenons anesthesia. The peripheral retinal zones may not be visualized adequately and remain poorly treated by laser. This is often evident by the posterior pole pepper-pot configuration of PRP Indirect PRP with subtenons anesthesia enables indented scleral laser application to up to the posterior border of the ora serrata. In PDR, the mid-peripheral retina up to the ora serrata is the zone of highest retinal ischemia as confirmed with widefield Optos the last 5 years, conventional long-pulse duration PRP treatment has changed. This is reflected in the new RCOphth Diabetic Retinopathy Guidelines 2012 published in the UK. The DRCRNet recommendations outlined in Table 5 are not routinely undertaken, as 1200-1600 burns delivered over 1-3 sittings is neither an efficient nor cost-effective treatment schedule for any resource-poor or resource-rich setting. In light of new short pulse settings, use of pattern scan laser, and new concepts on laser burn tissue interactions for PRP laser, laser practitioners globally are changing laser PRP treatment paradigms. There is a significant body of evidence to demonstrate that short pulse PRP laser treatment will produce less laser burn scarring, less damage to the visual field, and is less damaging to the retina than conventional long pulse 100ms PRP treatment. This is highlighted in the following section extracted from the UK RCOphth 2012 Healing Responses (Diabetic Retinopathy Guidelines 2012)The in vivo effects of 20ms burns have been demonstrated in animal studies. A potential explanation for laser burn healing responses is related to fluence, which is calculated as (power x time)/area. The fluence required to produce a threshold ETDRS type PRP burn on the retina is significantly lower for a pulse duration of 20ms compared with conventional 100ms pulse duration. A lower fluence laser dose results in fewer structural alterations in the outer retina. At shorter and longer pulse durations, the International Council of Ophthalmology | Guidelines for Diabetic Eye Care | Page 14Copyright ICO January 2017. Translation and adaption for non-commercial local use is encouraged, but please credit absorbs the laser light and is destroyed, and the adjacent RPE proliferates to fill the area destroyed. However, at shorter pulse duration, there is photoreceptor in-filling to sites of laser injury with healing responses produced over time. The MAPASS study showed that 20ms burns allow the tissues to undergo a healing response that may not occur after standard-duration (100-200ms) photocoagulation. This healing response is associated with a significant reduction in burn size across time for 20ms pulse duration, with no significant disruption to either the inner retina or the basal RPE. Higher-fluence 100ms burns developed larger defects due to thermal blooming and collateral damage, with no alteration in burn size across time or any healing laser-tissue interactions. Furthermore, at 6-months, the 20ms laser burns reduced in size without any overlapping laser scars, as the laser burns show healing responses over time. Hence, at different pulse durations, fluence should be titrated to achieve threshold burns in the outer retina, allowing for healing of laser burns and minimisation of photoreceptor injury. The short pulse (10-30ms) laser burn healing responses have since been reproduced by a number of International groups in the USA and Europe. For visible end-point laser PRP, a 20ms exposure time is preferable for PRP. This pulse duration can be achieved with standard laser systems as well as with the pattern scan laser systems. Exposure time should be titrated for individual patient as well as depending on laser reaction observed at given laser power setting. Subthreshold PRP is not effective in treating PDR, and there is a risk of bleeding complications due to under-treatment with a subthreshold PRP regimen. Below are the recommendations from the UK RCOphth 2012 guidelines, with 20ms laser PRP Settings1) Pulse Duration and Spot Size Use a 400 m retinal spot size. Smaller retinal spot size, 200 m and 300 m may lead to excessive higher fluence and risks of Bruch s rupture at 20ms exposure time. Furthermore, following laser burn healing, the final laser spot (burn) may be <100-150 m and patient will require more PRP ) Laser burn spacing Laser burns should be placed 1-burn widths apart for mild and moderate PDR. The space between the laser burns can be reduced for example, widths apart for severe PDR, TRD and vitreous hemorrhage, with a higher density and number of laser ) Laser burn intensity Laser surgeon should aim for a barely-visible, grey/white burn reaction on retina after laser application as the designated threshold. The laser surgeon should be aware that the laser burn intensity at 20ms will increase up to 1 minute after retinal ) Retinal surface coverage The PRP should be applied as far peripheral as possible using the laser contact lens, up to the ora serrata as the main areas of retinal ischemia in PDR exist in the far-peripheral retina while areas of ischemic penumbra is likely to be in pre-equatorial zones. Laser Strategy for Primary PRP 1) Early PDR Primary PRP should be completed by 2 weeks, fractionated if needed (1200- 1800 burns ETDRS strategy). If shorter duration of laser pulse (20ms) used, consider increasing number of laser burns appropriately, Based on laser burn ablation studies, approximately 2400-3500 burns using 20ms PRP are recommended for early PDR. Patient review: 4 months [in non-pregnant patient]. 2) Moderate PDR/High-risk PDR Primary PRP should be completed by 2 weeks, fractionated if needed (2000 -2500 burns ETDRS strategy). If shorter duration of laser pulse (20ms) used, consider increasing number of laser on laser burn ablation studies, approximately 4000-5000 burns using 20ms PRP are recommended for early PDR. A complete PRP treatment should be completed over 4 weeks with aiming to deliver more laser spots in the initial sessions. (Level A) Patient review: 3 months [in non-pregnant patient], however in poorly controlled diabetics, review interval should be shortened. 3) Severe PDR/High-risk PDR These cases are high risk of continued traction and hemorrhagic complications following PRP. Laser surgeon should aim to deliver full PRP coverage of peripheral retina (3000 burns ETDRS) over 2-3 sessions in 3-4 weeks. If shorter duration of laser pulse (20ms) used, consider increasing number of laser burns appropriately. Based on laser burn ablation studies, approximately 5500-6000 burns using 20ms PRP are recommended for early PDR. The complete PRP treatment should be completed over 4 weeks with aiming to deliver more laser spots in initial sessions. (Level A)International Council of Ophthalmology | Guidelines for Diabetic Eye Care | Page 15Copyright ICO January 2017. Translation and adaption for non-commercial local use is encouraged, but please credit B. Recommended Practice for Intravitreal InjectionIntravitreal injections may be performed in an office setting, or an operating InjectionsThe injection for each eye should be considered to be a separate procedure and should be performed accordingly, using separate site preparation and individual syringes, needles, a different medication batch, etc. Gloves Sterile or nonsterile gloves may be used. Talking and Use of MasksMinimizing speaking and/or by the use of surgical masks during the injection preparation and procedure is of Povidone Iodine to the Ocular Surface and EyelidsPovidone iodine (5 10%) should be the last agent applied to the intended injection site before injection. Povidone iodine may also be applied to the eyelid margins and eyelashes. After the final application of povidone iodine, the eyelashes and lid margins should not be allowed to come into contact with the injection site until the injection has been AnestheticsTopical anesthetics should be applied to minimize patient of InjectionIntravitreal injections should be given between the horizontal and vertical rectus muscles at the pars plana, to mm posterior to the limbus. Quadrant selection should be dictated by both patient-specific considerations and injecting physician preference. A simple perpendicular injection approach is both convenient and preferred in most Gauge and LengthA 30-gauge or smaller needle is generally preferred for anti-VEGF agents or nonviscous solutions. Larger bore needles can be considered for suspensions ( , steroids) and for solutions of higher viscosity. Needle length should be 5/8 inch (18 mm) or shorter but long enough to allow for complete penetration of the pars : Sequence of Events1. Either surgical masks should be used or both the patient and providers should minimize speaking during the injection preparation and procedure;2. Take a procedural time-out to verify patient, agent, and laterality;3. Apply liquid anesthetic drops to the ocular surface;4. Apply povidone iodine to the eyelashes and lid margins (optional, most use 10%);5. Retract the eyelids away from the intended injection site;6. Apply povidone iodine (most use 5%) to the conjunctival surface, including the intended injection site, at least 30 seconds before injection;7. If additional anesthetic is applied, reapply povidone iodine to the intended injection site immediately before injection (most use 5%);8. Insert the needle perpendicular to the sclera, to mm posterior to the limbus between the vertical and horizontal rectus Council of Ophthalmology | Guidelines for Diabetic Eye Care | Page 16Copyright ICO January 2017. Translation and adaption for non-commercial local use is encouraged, but please credit Table 1. Features of Diabetic Retinopathy (also see the photographs continued in the annex).FeatureDescriptionAssessment ConsiderationsMicroaneurysmsIsolated, spherical, red dots of varying size. They may reflect an abortive attempt to form a new vessel or may simply be a weakness of capillary vessel wall through loss of normal structural are easiest seen on fluorescein angiographyDot hemorrhagesDot hemorrhages cannot always be differentiated from microaneurysms as they are similar in appearance but with varying term dot hemorrhage/ microaneurysm (H/Ma) is often hemorrhagesFormed where clusters of capillaries occlude leading to formation of intraretinal blot lesion can be seen to be in the outer plexiform layer on fluorescein angiography where it does not mask the overlying capillary bed unlike dot and flame hemorrhages, which lie more superficially in the wool spotsThese represent the swollen ends of interrupted axons where build-up of axoplasmic flow occurs at the edge of the infarct. These features are not exclusive to DR and do not in themselves appear to increase the risk of new vessel formation. For example, they may occur in hypertension microvascular anomaliesThese are dilated capillary remnants following extensive closure of capillary network between arteriole and features include: Venous beading (foci of venous endothelial cell proliferation that have failed to develop into new vessels), Venous reduplication (rare), Venous loops (thought to develop due to small vessel occlusion and opening of alternative circulation) and Retinal pallor and white vesselsThey are easiest seen on fluorescein changes in nonproliferative retinopathy Macular edema Macrovascular diseaseThickening of retina takes place due to accumulation of exudative fluid from damaged outer blood-retina barrier (extracellular edema) or as a result of hypoxia, leading to fluid accumulating within individual retinal cells (intracellular edema). It may be focal or hemorrhage and cotton wool spot formation. May occur due to arteriolar occlusion, without capillary occlusion, which frequently affects the horizontal nerve fiber layer of the appearance of macular edema can be appreciated on stereoscopic examination or inferred by the presence of intraretinal disc changesOccasionally swollen optic discs may be seen (diabetic papillopathy) in diabetic diabetic papillopathy, vision is usually not significantly Council of Ophthalmology | Guidelines for Diabetic Eye Care | Page 17Copyright ICO January 2017. Translation and adaption for non-commercial local use is encouraged, but please credit Table 2. Features of Proliferative Diabetic ConsiderationsNew vessels at the disc (NVD)New vessels at the discs usually arise from the venous circulation on the disc or within 1 disc diameter of the disc NVD. In order to differentiate NVD from fine normal small blood vessels note that the latter always taper to an end and do not loop back to the disc, while NVD always loop back, may form a chaotic net within the loop, and have the top of the loop of wider diameter than the vessels elsewhere (NVE)New vessels, which usually occur along the border between healthy retina and areas of capillary to be confused with intraretinal microvascular abnormalities, which occur within areas of capillary sites of new vesselsNew vessel formation on the iris (NVI) is uncommon but represents potentially more advanced ischemic changes. New vessel formation on the anterior hyaloid surface occurs rarely postvitrectomy if insufficient laser has been applied to the peripheral is useful to perform gonioscopy in such cases to exclude new vessels in the anterior chamber angle (NVA), which can lead to neovascular proliferationIn proliferative retinopathy, new vessels grow on a platform of glial cellsAdapted from British The Royal College of Ophthalmologists Diabetic Retinopathy Guidelines December Table 3: Available Assessment Instruments and Their Advantages and DisadvantagesTechniqueRecommendationCommentsDirect ophthalmoscopy# Core for management Pupils must be dilatedAdvantages Mobile InexpensiveDisadvantages Requires pupil dilation Small field Low sensitivity: even with a trained practitioner and red free illumination, small microvascular abnormalities may be difficult to detect Less effective than slit- lamp biomicroscopy through dilated pupils No ability to retrospectively auditIndirect ophthalmoscopy# Core for management Pupils must be dilatedAdvantages Mobile Large field Relatively inexpensiveDisadvantages Requires pupil dilation Even with a trained practitioner and red free illumination, small microvascular abnormalities may be difficult to detect Less effective than slit- lamp biomicroscopy through dilated pupils No ability to retrospectively auditInternational Council of Ophthalmology | Guidelines for Diabetic Eye Care | Page 18Copyright ICO January 2017. Translation and adaption for non-commercial local use is encouraged, but please credit biomicroscopy Core for managementAdvantages Large fieldDisadvantages Requires pupil dilation Immobile Requires special lenses No ability to retrospectively auditNonmydriatic retinal photography Optional for screening and managementAdvantages Large field Can be used by non- medically trained staff No dilation required in 80-90% of cases Some are portable - can be transported to the community in mobile units Can be linked to computers and images can be stored for the long term Allows objective comparison of the same person, or between different groups of people, examined at different times or by different professionals Can be used as a patient education tool, giving immediacy and personal relevance Readily recalled for evaluation of screener performance and audit of grading AuditableDisadvantages Relatively expensive A dark space is required for maximum pupil dilationNonmydriatic retinal photography used with mydriasis Optional for screening and managementAdvantages As above except pupils are dilated for better quality photosDisadvantages As above Requires pupil dilationMydriatic retinal photography (conventional fundus camera) Optional for screening and managementAdvantages Large fieldDisadvantages Requires pupil dilation Expensive Bright flash constricts the pupil for a long timeFluorescein angiography Not recommended for screening and optional for managementAdvantages Only method of assessing capillary circulationDisadvantages Invasive and needs general health status assessment Expensive Dilatation needed. Cannot be used by non-medically trained staffOCT Optional for screening and managementAdvantages One of the best ways to assess macular edema (retinal thickening and intraretinal edema)Disadvantages Expensive Dilatation needed Cannot be used by non-medically trained staff(Continued) Annex Table 3: Available Assessment Instruments and Their Advantages and DisadvantagesInternational Council of Ophthalmology | Guidelines for Diabetic Eye Care | Page 19Copyright ICO January 2017. Translation and adaption for non-commercial local use is encouraged, but please credit History; Medical History; Current Medication; Biochemical ParametersAnnex Flowchart 1. Screening for Diabetic RetinopathyUncorrected Visual Acuity VA with current SpectaclesOphthalmoscopy or Fundus PhotographyVA better than 6/12 (20/40)VA 6/12 (20/40) or worseUrgent ReferralRoutine re-examinationNon-urgent Referral for refraction and assessment*Need to optimize medical treatment; glycemic control, hypertension and = non-proliferative diabetic retinopathyPDR = proliferative diabetic retinopathy DME=diabetic macular edemaVA=visual acuityDiabetic Retinopathy*NoneMild or ModerateNPDRSevere NPDR, DME,or PDRDiabetic macular edema (DME)Annex Flowchart 2: Treatment decision tree of DME based on Central-Involvement and to moderateModerate to severeNoncentral-involved Central-involved DMEVA better than 6/9 (20/30)VA 6/9 (20/30) or worseAnti-VEGF therapyFocal or grid laser photocoagulationTreatment failureClinicalOCTInternational Council of Ophthalmology | Guidelines for Diabetic Eye Care | Page 20Copyright ICO January 2017. Translation and adaption for non-commercial local use is encouraged, but please credit treatment for DMEAssessment 1 montha after initial injectionsbAnnex Flowchart 3: Anti-VEGF treatment decision tree based on the re-treatment and follow-up scheduleDME improvingca. In the study, 4-week, not 1-month, intervals were The study required 4 injections of intravitreal ranibizumab every 4 weeks initially; it is not known whether a different number of injections initially would have worked as well. also required 2 additional injections at months 5 and 6 if edema persisted and success had not been met, even in the absence of Relevant details from the study: 1) improvement on Zeiss Stratus OCT >10% decrease in central subfield thickness; 2) Even if no longer improving on OCT, injections continued if VA improvement (unless 6/6 or better); 3) VA improvement defined as 5 or more letter increase on Electronic ETDRS Visual Acuity In the study, if focal/grid laser was deferred at baseline, it was added at or after 24 weeks if edema still present and OCT central subfield and vision no longer In the study, all patients received at least 4 injections 4 weeks apart. The decision to re-inject was at investigator discretion, starting at 16 weeks for success , defined as VA better than 6/6 or OCT central subfield <250 m. Starting at 24 weeks, re-injection was also at investigator discretion if no improvement in OCT central subfield or The study continued to follow-up every 4 weeks through the 52-week visit and did not permit extension of follow-up until after the 52 week visit. If injection was withheld due to no improvement or success at 3 consecutive visits following the week 52 visit, follow-up interval was doubled to 8 weeks and then again to 16 weeks if still no endothelial growth factorDME=diabetic macular edemaVA=visual acuityNo injectione and return in 1 monthRe-inject and return in 1 monthDouble follow-up interval up to 4 monthsfDME worsens and recursNOdNOYESYESInternational Council of Ophthalmology | Guidelines for Diabetic Eye Care | Page 21Copyright ICO January 2017. Translation and adaption for non-commercial local use is encouraged, but please credit 1. Mild non-proliferative diabetic retinopathy with microaneurysmsFigure 2. Moderate non-proliferative diabetic retinopathy with hemorrhages, hard exudates and micro aneurysmsInternational Council of Ophthalmology | Guidelines for Diabetic Eye Care | Page 22Copyright ICO January 2017. Translation and adaption for non-commercial local use is encouraged, but please credit 3. Moderate non-proliferative diabetic retinopathy with moderate macular edema, with hard exudates approaching the center of the 4. Moderate non-proliferative diabetic retinopathy with no diabetic macular edema International Council of Ophthalmology | Guidelines for Diabetic Eye Care | Page 23Copyright ICO January 2017. Translation and adaption for non-commercial local use is encouraged, but please credit 5. Moderate non-proliferative diabetic retinopathy with mild diabetic macular edemaFigure 6. Moderate non-proliferative diabetic retinopathy with severe macular edemaInternational Council of Ophthalmology | Guidelines for Diabetic Eye Care | Page 24Copyright ICO January 2017. Translation and adaption for non-commercial local use is encouraged, but please credit 7a. Moderate non-proliferative diabetic retinopathy with moderate macular edemaFigure 7b. Fundus Fluorescein Angiogram showing moderate non-proliferative diabetic retinopathy with moderate macular edema International Council of Ophthalmology | Guidelines for Diabetic Eye Care | Page 25Copyright ICO January 2017. Translation and adaption for non-commercial local use is encouraged, but please credit 8. Severe nonproliferative diabetic retinopathy with severe diabetic macular 9. Severe nonproliferative diabetic retinopathy with severe diabetic macular Council of Ophthalmology | Guidelines for Diabetic Eye Care | Page 26Copyright ICO January 2017. Translation and adaption for non-commercial local use is encouraged, but please credit 10. Severe nonproliferative diabetic retinopathy with venous 11. Severe nonproliferative diabetic retinopathy with intra retinal microvascular abnormality (IRMA).International Council of Ophthalmology | Guidelines for Diabetic Eye Care | Page 27Copyright ICO January 2017. Translation and adaption for non-commercial local use is encouraged, but please credit 13. High risk proliferative diabetic retinopathy with new vessels at the disc Figure 12. Proliferative diabetic retinopathy with venous beading, new vessels elsewhere (NVE) and severe diabetic macular edemaInternational Council of Ophthalmology | Guidelines for Diabetic Eye Care | Page 28Copyright ICO January 2017. Translation and adaption for non-commercial local use is encouraged, but please credit 14a. High risk proliferative diabetic retinopathy. Pre-retinal hemorrhage before with new vessels on the 14b. High risk proliferative diabetic retinopathy, with new panretinal photocoagulation (PRP) scars International Council of Ophthalmology | Guidelines for Diabetic Eye Care | Page 29Copyright ICO January 2017. Translation and adaption for non-commercial local use is encouraged, but please credit 15a. Proliferative diabetic retinopathy. New vessels on the disc and elsewhere Figure 15b. Proliferative diabetic retinopathy. New vessels on the disc and elsewhere on fluorescein angiogram International Council of Ophthalmology | Guidelines for Diabetic Eye Care | Page 30Copyright ICO January 2017. Translation and adaption for non-commercial local use is encouraged, but please credit 16a. Diabetic macular edema with panretinal photocoagulation (PRP) (right eye). Figure 16b. Diabetic macular edema with panretinal photocoagulation (PRP). (left eye)International Council of Ophthalmology | Guidelines for Diabetic Eye Care | Page 31Copyright ICO January 2017. Translation and adaption for non-commercial local use is encouraged, but please credit 17a. Persistent diabetic macular edema after focal laser treatment Figure 17b. Persistent diabetic macular edema after focal laser treatment on fundus fluorescein angiogramInternational Council of Ophthalmology | Guidelines for Diabetic Eye Care | Page 32Copyright ICO January 2017. Translation and adaption for non-commercial local use is encouraged, but please credit 18a. Proliferative diabetic retinopathy with pre-retinal hemorrhage Figure 18b. Proliferative diabetic retinopathy with pre-retinal hemorrhage on fundus fluorescein angiogramNew Vessels on the Disc and Fibrous ProliferationPre-Retinal HemorrhageNew Vessels on the Disc and Fibrous ProliferationPre-Retinal HemorrhageInternational Council of Ophthalmology | Guidelines for Diabetic Eye Care | Page 33Copyright ICO January 2017. Translation and adaption for non-commercial local use is encouraged, but please credit 19. Panretinal (PRP) photocoagulation. First session: inferior retina (laser scars). Second session: superior retina (fresh burns). Third session will be needed to complete 20. Optical coherence tomography (OCT) showing diabetic macular edema with thickened retina and intra-retinal cystic changesInternational Council of Ophthalmology | Guidelines for Diabetic Eye Care | Page 34Copyright ICO January 2017. Translation and adaption for non-commercial local use is encouraged, but please credit for Screening, Assessing, and Treating Diabetic Eye Disease To create the International Council of Ophthalmology (ICO) Guidelines for Diabetic Eye Care, the ICO collected guidelines from around the world for screening, assessing, and treating diabetic eye disease. This is part of an ICO initiative to reduce worldwide vision loss related to diabetes. In addition to creating a consensus on technical guidelines, as encompassed in the ICO Guidelines for Diabetic Eye Care, these resources will also be used to focus on: Incorporating the critical competencies into ICO curricula and stimulating improved training and continuing professional development to meet public needs. Developing a framework for evaluation of public health approaches and stimulating development, strengthening, and monitoring of relevant health systems. Please send questions, comments, or additional resources to: the ICOThe ICO is composed of over 140 national and subspecialty Member societies from around the globe. ICO Member societies are part of an international ophthalmic community working together to preserve and restore vision. Learn more at: CreditThe photos that appear in the ICO Guidelines for Diabetic Eye Care were provided by: Pan-American Association of Ophthalmology (Figure 19) Singapore Eye Research Institute, Singapore National Eye Center (cover photos and Figures 1-18b and Figure 20) University of Melbourne, cover photo (bottom right)*Photos may be used in translated or adapted versions of the ICO Guidelines for Diabetic Eye Care. They may not be used for commercial purposes. If the photos are used, credit must be given to the appropriate organization(s).ICO Guidelines for Diabetic Eye Care Usage Rights Translation and adaption of ICO Guidelines for Diabetic Eye Care for non-commercial local use is encouraged, but please credit ICO. Copyright 2017, International Council of Ophthalmology. All Rights to volunteer translators, translations of the ICO Guidelines for Diabetic Eye Care are available in selected languages and editions on the ICO website. Please contact the ICO if you are interested in helping translate the Guidelines into another language. Download ICO Guidelines for Diabetic Eye Care at: UsICO Headquarters: 711 Van Ness Ave., Suite #445 San Francisco, California 94102 United States of AmericaFax: +1 415 521 1649 Phone: +1 415 521 1651 Email: Web:

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