Diabetic Retinopathy Preferred Practice Pattern®

AMERICAN ACADEMY OF OPHTHALMOLOGY® Protecting Sight. Empowering Lives.® © 2019 by the American Academy of Ophthalmology Published by Elsevier Inc. http://dx.doi.org/10.1016/j.ophtha.2019.09.025 ISSN 0161–6420/19 Secretary for Quality of Care: Timothy W. Olsen, MD Academy Staff: Ali Al-Rajhi, PhD, MPH Andre Ambrus, MLIS Meghan Daly Flora C. Lum, MD Medical Editor: Susan Garratt Approved by: Board of Trustees September 7, 2019 © 2019 American Academy of Ophthalmology® All rights reserved AMERICAN ACADEMY OF OPHTHALMOLOGY and PREFERRED PRACTICE PATTERN are registered trademarks of the American Academy of Ophthalmology. All other trademarks are the property of their respective owners. Preferred Practice Pattern® guidelines are developed by the Academy's H. Dunbar Hoskins Jr., MD Center for Quality Eye Care without any external financial support. Authors and reviewers of the guidelines are volunteers and do not receive any financial compensation for their contributions to the documents. The guidelines are externally reviewed by experts and stakeholders before publication. Correspondence: Ali A. Al-Rajhi, PhD, MPH American Academy of Ophthalmology, P. O. Box 7424, San Francisco, CA 94120–7424. E-mail: . The Retina/Vitreous Preferred Practice Pattern® Panel members wrote the Diabetic Retinopathy Preferred Practice Pattern® (PPP) guidelines. The PPP Panel members discussed and reviewed successive drafts of the document, meeting in person twice and conducting other review by e-mail discussion, to develop a consensus over the final version of the document. Retina/Vitreous Preferred Practice Pattern Panel 2018–2019 Steven T. Bailey, MD, Retina Society Representative Amani Fawzi, MD, Macula Society Representative Jennifer I. Lim, MD Ron A. Adelman, MD, MPH, MBA, FACS Gurunadh A. Vemulakonda, MD, American Society of Retina Specialists Representative Gui-shang Ying, MD, PhD, Methodologist Christina J. Flaxel, MD, Chair We thank our partners, the Cochrane Eyes and Vision US Satellite ([email protected]), for identifying reliable systematic reviews that we cite and discuss in support of the PPP recommendations. The Preferred Practice Patterns Committee members reviewed and discussed the document during a meeting in June 2019. The document was edited in response to the discussion and comments. Preferred Practice Patterns Committee 2019 Robert S. Feder, MD, Chair Roy S. Chuck, MD, PhD Steven P. Dunn, MD Christina J. Flaxel, MD Steven J. Gedde, MD Francis S. Mah, MD Randall J. Olson, MD David K. Wallace, MD, MPH David C. Musch, PhD, MPH, Methodologist The Diabetic Retinopathy PPP was then sent for review to additional internal and external groups and individuals in July 2019. All those returning comments were required to provide disclosure of relevant relationships with industry to have their comments considered (indicated with an asterisk below). Members of the Retina/Vitreous Preferred Practice Pattern Panel reviewed and discussed these comments and determined revisions to the document. In compliance with the Council of Medical Specialty Societies' Code for Interactions with Companies (available at www.cmss.org/codeforinteractions.aspx). relevant relationships with industry are listed. The Academy has Relationship with Industry Procedures to comply with the Code (available at http://one.aao.org/CE/PracticeGuidelines/PPP.aspx). A majority (88%) of the members of the Retina/Vitreous Preferred Practice Pattern Panel 2018–2019 had no financial relationship to disclose. Retina/Vitreous Preferred Practice Pattern Panel 2018–2019 Christina J. Flaxel, MD: No financial relationships to disclose Ron A. Adelman, MD, MPH, MBA, FACS: No financial relationships to disclose Steven T. Bailey, MD: No financial relationships to disclose Amani Fawzi, MD: No financial relationships to disclose Jennifer I. Lim, MD: Alcon Laboratories, Genentech, Kodiak Sciences, EyePoint Pharmaceuticals— Consultant/Advisor; Genentech—Lecture Fees Gurunadh A. Vemulakonda, MD: No financial relationships to disclose Gui-shang Ying, MD, PhD: No financial relationships to disclose Preferred Practice Patterns Committee 2019 Robert S. Feder, MD, Chair: No financial relationships to disclose Roy S. Chuck, MD, PhD: Novartis, Shire—Consultant/Advisor Steven P. Dunn, MD: No financial relationships to disclose Christina J. Flaxel, MD: No financial relationships to disclose Steven J. Gedde, MD: No financial relationships to disclose Francis S. Mah, MD: Aerie Pharmaceuticals, Bausch + Lomb, EyePoint Pharmaceuticals, Novartis, Ocular Therapeutix, Shire, Sun Pharma—Consultant/Advisor; Bausch + Lomb, Novartis, Shire, Sun Pharma—Lecture Fees Randall J. Olson, MD: No financial disclosures David K. Wallace, MD, MPH: No financial disclosures David C. Musch, PhD, MPH, Methodologist:, IRIDEX, Notal Vision—Consultant/Advisor Secretary for Quality of Care Timothy W. Olsen, MD: No financial relationships to disclose Academy Staff Ali Al-Rajhi, PhD, MPH: No financial relationships to disclose Andre Ambrus, MLIS: No financial relationships to disclose Meghan Daly: No financial relationships to disclose Flora C. Lum, MD: No financial relationships to disclose The disclosures of relevant relationships to industry of other reviewers of the document from January to October 2019 are available online at www.aao.org/ppp. OBJECTIVES OF PREFERRED PRACTICE PATTERN GUIDELINES P72METHODS AND KEY TO RATINGS P73HIGHLIGHTED FINDINGS AND RECOMMENDATIONS FOR CARE P74INTRODUCTION P75Disease Definition P75Patient Population P75Clinical Objectives P75BACKGROUND P76Introduction P76Prevalence of Diabetes P76Prevalence of Diabetic Retinopathy P77Risk Factors P78Natural History P80CARE PROCESS P83Patient Outcome Criteria P84Diagnosis P84History P84Examination P84Examination Schedule P85Ancillary Tests P86Management P89Prevention of Diabetic Retinopathy P89Early Detection of Diabetic Retinopathy P90Medical and Surgical Management P91Follow-up Evaluation P104Provider and Setting P104Counseling and Referral P104Socioeconomic Considerations P105APPENDIX 1. QUALITY OF OPHTHALMIC CARE CORE CRITERIA P106APPENDIX 2. INTERNATIONAL STATISTICAL CLASSIFICATION OF DISEASES AND RELATED HEALTH PROBLEMS (ICD) CODES P108APPENDIX 3. MAJOR STUDY RESULTS P110APPENDIX 4. GLYCEMIC CONTROL P119APPENDIX 5. CLASSIFICATION OF DIABETIC RETINOPATHY IN THE EARLY TREATMENT OF DIABETIC RETINOPATHY STUDY P123GLOSSARY P124LITERATURE SEARCHES FOR THIS PPP P129RELATED ACADEMY MATERIALS P130REFERENCES P131 Background: Diabetic retinopathy is a leading cause of visual impairment in working-age adults worldwide. Duration of diabetes is a major risk factor associated with the development of diabetic retinopathy. Due to the disproportionately large number of patients with type 2 diabetes, this group comprises a larger proportion of the disease burden in patients with visual impairment from diabetic retinopathy compared to patients with type 1 diabetes. The recommendations of this Preferred Practice Pattern are based on Cochrane-identified reliable systematic reviews. Rationale for treatment: Both clinical trials and epidemiological studies have shown that the two key modifiable risk factors associated with developing diabetic retinopathy are blood sugar and blood pressure control. Maintaining near-normal glucose levels and near-normal blood pressure lowers the risk of retinopathy developing and/or progressing. Care Process: The care process for diabetic retinopathy includes a medical history, a regular ophthalmologic examination or screening of high-quality retinal photographs of patients who have not had previous treatment for diabetic retinopathy or other eye disease, and regular follow-up. The goal of treatment is to improve or stabilize visual function, improve vision-related quality of life; and, through close communication with the patient's primary care physician achieve optimal control of blood glucose, blood pressure and other metabolic risk factors. The initial examination for a patient with diabetes mellitus includes all features of the comprehensive adult medical eye evaluation, with particular attention to those aspects relevant to diabetic retinopathy. The examination schedule is detailed in this Preferred Practice Pattern for patients diagnosed with type 1 or type 2 diabetes. Additionally, ancillary tests (e.g., fundus photography, OCT, and FA) to clinical examinations may enhance patient care. Management options for diabetic retinopathy includes following a healthy diet and lifestyle, medical management, timely ophthalmic evaluation, and treatment under the care of an ophthalmologist. Cost-effective treatments with laser, anti-VEGF agents, or intravitreal corticosteroids may also be considered. Because patients with diabetes may be under the care of multiple practitioners, effective communication and care coordination is necessary to optimize care. As a service to its members and the public, the American Academy of Ophthalmology has developed a series of Preferred Practice Pattern® guidelines that identify characteristics and components of quality eye care. Appendix 1 describes the core criteria of quality eye care. The Preferred Practice Pattern® guidelines are based on the best available scientific data as interpreted by panels of knowledgeable health professionals. In some instances, such as when results of carefully conducted clinical trials are available, the data are particularly persuasive and provide clear guidance. In other instances, the panels have to rely on their collective judgment and evaluation of available evidence. These documents provide guidance for the pattern of practice, not for the care of a particular individual. While they should generally meet the needs of most patients, they cannot possibly best meet the needs of all patients. Adherence to these PPPs will not ensure a successful outcome in every situation. These practice patterns should not be deemed inclusive of all proper methods of care or exclusive of other methods of care reasonably directed at obtaining the best results. It may be necessary to approach different patients' needs in different ways. The physician must make the ultimate judgment about the propriety of the care of a particular patient in light of all of the circumstances presented by that patient. The American Academy of Ophthalmology is available to assist members in resolving ethical dilemmas that arise in the course of ophthalmic practice. Preferred Practice Pattern® guidelines are not medical standards to be adhered to in all individual situations. The Academy specifically disclaims any and all liability for injury or other damages of any kind, from negligence or otherwise, for any and all claims that may arise out of the use of any recommendations or other information contained herein. References to certain drugs, instruments, and other products are made for illustrative purposes only and are not intended to constitute an endorsement of such. Such material may include information on applications that are not considered community standard, that reflect indications not included in approved U.S. Food and Drug Administration (FDA) labeling, or that are approved for use only in restricted research settings. The FDA has stated that it is the responsibility of the physician to determine the FDA status of each drug or device he or she wishes to use, and to use them with appropriate patient consent in compliance with applicable law. Innovation in medicine is essential to ensure the future health of the American public, and the Academy encourages the development of new diagnostic and therapeutic methods that will improve eye care. It is essential to recognize that true medical excellence is achieved only when the patients' needs are the foremost consideration. All Preferred Practice Pattern® guidelines are reviewed by their parent panel annually or earlier if developments warrant and updated accordingly. To ensure that all PPPs are current, each is valid for 5 years from the approved by date unless superseded by a revision. Preferred Practice Pattern guidelines are funded by the Academy without commercial support. Authors and reviewers of PPPs are volunteers and do not receive any financial compensation for their contributions to the documents. The PPPs are externally reviewed by experts and stakeholders, including consumer representatives, before publication. The PPPs are developed in compliance with the Council of Medical Specialty Societies' Code for Interactions with Companies. The Academy has Relationship with Industry Procedures (available at www.aao.org/about-preferred-practice-patterns) to comply with the Code. Appendix 2 contains the International Statistical Classification of Diseases and Related Health Problems (ICD) codes for the disease entities that this PPP covers. The intended users of the Diabetic Retinopathy PPP are ophthalmologists. Preferred Practice Pattern® guidelines should be clinically relevant and specific enough to provide useful information to practitioners. Where evidence exists to support a recommendation for care, the recommendation should be given an explicit rating that shows the strength of evidence. To accomplish these aims, methods from the Scottish Intercollegiate Guideline Network1Ferris F Early photocoagulation in patients with either type I or type II diabetes.Trans Am Ophthalmol Soc. 1996; 94: 505-537PubMed Google Scholar (SIGN) and the Grading of Recommendations Assessment, Development and Evaluation2Guyatt GH Oxman AD Vist GE et al.GRADE: an emerging consensus on rating quality of evidence and strength of recommendations.BMJ. 2008; 336: 924-926Crossref PubMed Google Scholar (GRADE) group are used. GRADE is a systematic approach to grading the strength of the total body of evidence that is available to support recommendations on a specific clinical management issue. Organizations that have adopted GRADE include SIGN, the World Health Organization, the Agency for Healthcare Research and Policy, and the American College of Physicians.3GRADE Working Group Organizations that have endorsed or that are using GRADE.http://www.gradeworkinggroup.org/Date accessed: September , 2019Google Scholar ♦All studies used to form a recommendation for care are graded for strength of evidence individually, and that grade is listed with the study citation.♦To rate individual studies, a scale based on SIGN1Ferris F Early photocoagulation in patients with either type I or type II diabetes.Trans Am Ophthalmol Soc. 1996; 94: 505-537PubMed Google Scholar is used. The definitions and levels of evidence to rate individual studies are as follows: Tabled 1I++High-quality meta-analyses, systematic reviews of randomized controlled trials (RCTs), or RCTs with a very low risk of biasI+Well-conducted meta-analyses, systematic reviews of RCTs, or RCTs with a low risk of biasI-Meta-analyses, systematic reviews of RCTs, or RCTs with a high risk of biasII++High-quality systematic reviews of case-control or cohort studiesHigh-quality case-control or cohort studies with a very low risk of confounding or bias and a high probability that the relationship is causalII+Well-conducted case-control or cohort studies with a low risk of confounding or bias and a moderate probability that the relationship is causalII-Case-control or cohort studies with a high risk of confounding or bias and a significant risk that the relationship is not causalIIINonanalytic studies (e.g., case reports, case series) Open table in a new tab ♦Recommendations for care are formed based on the body of the evidence. The body of evidence quality ratings are defined by GRADE2Guyatt GH Oxman AD Vist GE et al.GRADE: an emerging consensus on rating quality of evidence and strength of recommendations.BMJ. 2008; 336: 924-926Crossref PubMed Google Scholar as follows: Tabled 1Good qualityFurther research is very unlikely to change our confidence in the estimate of effectModerate qualityFurther research is likely to have an important impact on our confidence in the estimate of effect and may change the estimateInsufficient qualityFurther research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate Any estimate of effect is very uncertain Open table in a new tab ♦Key recommendations for care are defined by GRADE2Guyatt GH Oxman AD Vist GE et al.GRADE: an emerging consensus on rating quality of evidence and strength of recommendations.BMJ. 2008; 336: 924-926Crossref PubMed Google Scholar as follows: Tabled 1Adapted with permission from Wilkinson CP, Ferris FL III, Klein RE, et al. Proposed international clinical diabetic retinopathy and diabetic macular edema disease severity scales. Ophthalmology 2003:110:1679Strong recommendationUsed when the desirable effects of an intervention clearly outweigh the undesirable effects or clearly do notDiscretionary recommendationUsed when the trade-offs are less certain—either because of low-quality evidence or because evidence suggests that desirable and undesirable effects are closely balanced Open table in a new tab ♦The Highlighted Findings and Recommendations for Care section lists points determined by the PPP Panel to be of particular importance to vision and quality of life outcomes.♦All recommendations for care in this PPP were rated using the system described above. Ratings are embedded throughout the PPP main text in italics.♦Literature searches to update the PPP were undertaken in April 2018 and June 2019 in PubMed and the Cochrane Library. Complete details of the literature searches are available online at www.aao.org/ppp. The prevalence of diabetes is increasing with increasing industrialization and globalization. Consequently, the prevalence of diabetic retinopathy and vision-threatening diabetic retinopathy is also expected to increase. Only about 60% of people with diabetes have recommended yearly screenings for diabetic retinopathy. Referral to an ophthalmologist is required when there is any evidence of diabetic retinopathy. People with type 1 diabetes should have annual screenings for diabetic retinopathy beginning 5 years after the onset of their disease, whereas those with type 2 diabetes should have a prompt screening at the time of diagnosis and at least yearly screenings thereafter. Maintaining control of glucose and blood pressure lowers the risk of retinopathy developing and/or progressing, so patients should be informed of the importance of maintaining good levels of glycosylated hemoglobin, and blood pressure. Patients with diabetes may use aspirin for other medical indications (as antiplatelet therapy) without an adverse effect on their risk of diabetic retinopathy. Women with diabetes who become pregnant should be examined early and closely in the course of the pregnancy because the disease can progress rapidly. However, an eye examination is not required when gestational diabetes occurs during pregnancy. Patients with diabetes have an accelerated rate of diabetic retinopathy progression during puberty and should be followed more closely. Intravitreal anti-vascular endothelial growth factor (anti-VEGF) agents are effective in the treatment of center-involved diabetic macular edema with vision loss. At this time, laser photocoagulation surgery remains the preferred treatment for non-center-involved diabetic macular edema and pan-retinal photocoagulation (PRP) surgery remains the mainstay treatment for proliferative diabetic retinopathy (PDR). Diabetic retinopathy is a common complication in type 1 and type 2 diabetes. Diabetic retinopathy is the ocular manifestation of end-organ damage in diabetes mellitus.4Shah AR Gardner TW Diabetic retinopathy: research to clinical practice.Clin Diabetes Endocrinol. 2017; 3: 9Crossref PubMed Google Scholar Diabetic retinopathy has been classically considered as a microvascular disease of the retina. However, growing evidence suggests that retinal neurodegeneration is an early event in the pathogenesis of diabetic retinopathy, which could contribute to the development of microvascular abnormalities.5Abcouwer SF Gardner TW Diabetic retinopathy: loss of neuroretinal adaptation to the diabetic metabolic environment.Ann N Y Acad Sci. 2014; 1311: 174-190Crossref PubMed Scopus (83) Google Scholar Although defects in neurosensory function have been demonstrated in patients with diabetes mellitus prior to the onset of vascular lesions, the most common early clinically visible manifestations of diabetic retinopathy include microaneurysm formation and intraretinal hemorrhages. Microvascular damage leads to retinal capillary nonperfusion, cotton wool spots, an increased number of hemorrhages, venous abnormalities, and intraretinal microvascular abnormalities (IRMA). During this stage, increased vasopermeability can result in retinal thickening (edema) and/or exudates that may lead to a loss in central visual acuity. The proliferative stage results in proliferation of new vessels on the disc, retina, and iris, and in the filtration angle. These new vessels then lead to traction retinal detachments and neovascular glaucoma, respectively. Vision can be substantially impaired in this stage as a result of capillary nonperfusion or edema in the macula, vitreous hemorrhage, and distortion or traction retinal detachment. A description of the fundus findings in various stages of diabetic retinopathy is included in the Natural History section, and important terms are defined in the Glossary. The patient population includes all patients with diabetes mellitus. ♦Identify patients at risk of developing diabetic retinopathy♦Encourage a collaborative approach between the patient, the primary care physician, and subspecialists in the management of the patient's systemic disorder, with specific attention to control of blood sugar (hemoglobin A1c [HbA1c]), blood pressure, serum lipids, body weight, and the management of renal disease, coronary artery disease,6Kawasaki R Tanaka S Abe S et al.Japan Diabetes Complications Study GroupRisk of cardiovascular diseases is increased even with mild diabetic retinopathy: the Japan Diabetes Complications Study.Ophthalmology. 2013; 120: 574-582Abstract Full Text Full Text PDF PubMed Scopus (0) Google Scholar and neuropathy♦Encourage and provide lifelong monitoring of retinopathy progression♦Treat patients with visual loss or those at risk for visual loss from diabetic retinopathy♦Minimize the side effects of treatment that might adversely affect the patient's vision and/or vision-related quality of life♦Provide or refer for visual rehabilitation services when a patient has visual impairment from the disease♦Refer for ophthalmological follow-up for potentially reversable vision loss such as cataracts, glaucoma, or refractive changes♦Develop new technologies for telemedicine improvement