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DIABETIC RETINOPATHY SUMMARY BENCHMARKS

FOR PREFERRED PRACTICE PATTERN® GUIDELINES

Introduction literature search of PubMed and the Cochrane Library


These are summary benchmarks for the Academy’s for articles in the English language is conducted. The
Preferred Practice Pattern® (PPP) guidelines. The results are reviewed by an expert panel and used to pre-
Preferred Practice Pattern series of guidelines has been pare the recommendations, which are then given a rating
written on the basis of three principles. that shows the strength of evidence when sufficient evi-
dence exists.
• Each Preferred Practice Pattern should be clinically
relevant and specific enough to provide useful To rate individual studies, a scale based on the Scottish
information to practitioners. Intercollegiate Guideline Network (SIGN) is used. The
• Each recommendation that is made should be given definitions and levels of evidence to rate individual stud-
an explicit rating that shows its importance to the ies are as follows:
care process. • I++: High-quality meta-analyses, systematic reviews of
• Each recommendation should also be given an explicit randomized controlled trials (RCTs), or RCTs with a
rating that shows the strength of evidence that very low risk of bias
supports the recommendation and reflects the best • I+: Well-conducted meta-analyses, systematic reviews
evidence available. of RCTs, or RCTs with a low risk of bias
Preferred Practice Patterns provide guidance for the pat- • I–: Meta-analyses, systematic reviews of RCTs, or
tern of practice, not for the care of a particular individ- RCTs with a high risk of bias
ual. While they should generally meet the needs of most • II++: High-quality systematic reviews of case-control
patients, they cannot possibly best meet the needs of all or cohort studies; high-quality case-control or cohort
patients. Adherence to these Preferred Practice Patterns studies with a very low risk of confounding or bias and
will not ensure a successful outcome in every situation. a high probability that the relationship is causal
These practice patterns should not be deemed inclusive of • II+: Well-conducted case-control or cohort studies
all proper methods of care or exclusive of other methods with a low risk of confounding or bias and a moderate
of care reasonably directed at obtaining the best results. probability that the relationship is causal
It may be necessary to approach different patients’ needs
in different ways. The physician must make the ultimate • II–: Case-control or cohort studies with a high risk of
judgment about the propriety of the care of a particular confounding or bias and a significant risk that the rela-
patient in light of all of the circumstances presented by tionship is not causal
that patient. The American Academy of Ophthalmology • III: Nonanalytic studies (e.g., case reports, case series)
is available to assist members in resolving ethical dilem-
mas that arise in the course of ophthalmic practice. Recommendations for care are formed based on the body
of the evidence. The body of evidence quality ratings are
The Preferred Practice Pattern® guidelines are not medi- defined by Grading of Recommendations Assessment,
cal standards to be adhered to in all individual situations. Development and Evaluation (GRADE) as follows:
The Academy specifically disclaims any and all liability • Good quality (GQ): Further research is very unlikely to
for injury or other damages of any kind, from negligence change our confidence in the estimate of effect
or otherwise, for any and all claims that may arise out
• Moderate quality (MQ): Further research is likely to
of the use of any recommendations or other information
have an important impact on our confidence in the
contained herein.
estimate of effect and may change the estimate
For each major disease condition, recommendations for • Insufficient quality (IQ): Further research is very likely
the process of care, including the history, physical exam to have an important impact on our confidence in the
and ancillary tests, are summarized, along with major estimate of effect and is likely to change the estimate;
recommendations for the care management, follow-up, any estimate of effect is very uncertain
and education of the patient. For each PPP, a detailed

Copyright © American Academy of Ophthalmology, November 2015 • www.aao.org 1


DIABETIC RETINOPATHY SUMMARY BENCHMARKS
FOR PREFERRED PRACTICE PATTERN® GUIDELINES
Introduction (continued)

Key recommendations for care are defined by GRADE as This former approach, however, will eventually be phased
follows: out as the AAO adopted the SIGN and GRADE rating
• Strong recommendation (SR): Used when the desirable and grading systems.
effects of an intervention clearly outweigh the undesir-
able effects or clearly do not The PPPs are intended to serve as guides in patient care,
with greatest emphasis on technical aspects. In applying
• Discretionary recommendation (DR): Used when the this knowledge, it is essential to recognize that true medi-
trade-offs are less certain—either because of low- cal excellence is achieved only when skills are applied in
quality evidence or because evidence suggests that a such a manner that the patients’ needs are the foremost
desirable and undesirable effects are closely balanced consideration. The AAO is available to assist members
in resolving ethical dilemmas that arise in the course of
In PPPs prior to 2011, the panel rated recommendations practice. (AAO Code of Ethics)
according to its importance to the care process. This
“importance to the care process” rating represents care
that the panel thought would improve the quality of the
patient’s care in a meaningful way. The ratings of impor-
tance are divided into three levels.
• Level A, defined as most important
• Level B, defined as moderately important
• Level C, defined as relevant but not critical

The panel also rated each recommendation on the


strength of evidence in the available literature to support
the recommendation made. The “ratings of strength of
evidence” also are divided into three levels.
• Level I includes evidence obtained from at least
one properly conducted, well-designed randomized
controlled trial. It could include meta-analyses of
randomized controlled trials.
• Level II includes evidence obtained from the following:
• Well-designed controlled trials without randomization
• Well-designed cohort or case-control analytic studies,
preferably from more than one center
• Multiple-time series with or without the intervention
• Level III includes evidence obtained from one of the
following:
• Descriptive studies
• Case reports
• Reports of expert committees/organizations (e.g.,
PPP panel consensus with external peer review)

Copyright © American Academy of Ophthalmology, November 2015 • www.aao.org 2


Diabetic Retinopathy (Initial and Follow-up Evaluation)

Initial Exam History (Key elements) Ancillary Tests


• Duration of diabetes (II++, GQ, SR) • Optical coherence tomography can be used to quantify
• Past glycemic control (hemoglobin A1c) (II++, GQ, SR) retinal thickness, monitor macular edema, identify vit-
reomacular traction, and detect other forms of macu-
• Medications (III, GQ, SR) lar disease in patients with diabetic macular edema.
• Medical history (e.g., obesity, renal disease, systemic (III, GQ, SR) Decisions to repeat anti-VEGF injections,
hypertension, serum lipid levels, pregnancy) (II++, GQ, SR) change therapeutic agents (e.g., use of intraocular cor-
• Ocular history (III, GQ, SR) ticosteroids), initiate laser treatment, or even consider
vitrectomy surgery are often based in part on OCT
Initial Physical Exam (Key elements) findings.
• Visual acuity (III, GQ, SR) • Fundus photography may be useful for documenting
the presence of NVE and NVD, the response to treat-
• Slit-lamp biomicroscopy (III, GQ, SR)
ment, and the need for additional treatment at future
• Measurement of IOP (III, GQ, SR) visits. (III, IQ, SR)
• Gonioscopy before dilation when indicated (for neo- • Fluorescein angiography is used as a guide for laser
vascularization of the iris or increased IOP) (III, GQ, SR) treatment of CSME and as a means of evaluating the
• Pupillary assessment for optic nerve dysfunction cause(s) of unexplained decreased visual acuity. (III, IQ,
SR) Angiography can identify macular capillary non-
• Thorough funduscopy including stereoscopic examina-
perfusion or sources of capillary leakage resulting in
tion of the posterior pole (III, GQ, SR)
macular edema as possible explanations for visual loss.
• Examination of the peripheral retina and vitreous, (III, IQ, SR)
best performed with indirect ophthalmoscopy or
• Fluorescein angiography is not routinely indicated as
with slit-lamp biomicroscopy (III, GQ, SR)
a part of the examination of patients with diabetes.
(III, GQ, SR)
Diagnosis
• Ultrasonography enables assessment of the status of
• Classify both eyes as to category and severity of dia-
the retina in the presence of a vitreous hemorrhage or
betic retinopathy and macular edema. (III, GQ, SR) Each
other media opacity, and may be helpful to define the
category has an inherent risk for progression and is
extent and severity of vitreoretinal traction, especially
dependent on adherence to overall diabetes control.
on the macula of diabetic eyes. (III, GQ, SR)
Follow-up History
Patient Education
• Visual symptoms (II+, GQ, SR)
• Discuss results of exam and implications
• Systemic status (pregnancy, blood pressure, serum
• Encourage patients with diabetes but without dia-
cholesterol, renal status) (III, GQ, SR)
betic retinopathy to have annual dilated eye exams
• Glycemic status (hemoglobin A1c) (III, GQ, SR) (II++, GQ, SR)
• Inform patients that effective treatment for diabetic ret-
Follow-up Physical Exam
inopathy depends on timely intervention, despite good
• Visual acuity (III, GQ, SR) vision and no ocular symptoms
• Measurement of IOP (III, GQ, SR) • Educate patients about the importance of maintaining
• Slit-lamp biomicroscopy with iris examination near-normal glucose levels and near-normal blood
(III, GQ, SR) pressure and lowering serum lipid levels (III, GQ, SR)
• Gonioscopy (preferably before dilation when iris • Communicate with the attending physician, e.g., family
neovascularization is suspected or if IOP is elevated) physician, internist, or endocrinologist, regarding eye
(III, GQ, SR) findings (III, GQ, SR)
• Stereoscopic examination of the posterior pole after • Provide patients whose conditions fail to respond to
dilation of the pupils (III, GQ, SR) surgery and for whom further treatment is unavailable
• Examination of the peripheral retina and vitreous with proper professional support and offer referral
when indicated (III, GQ, SR) for counseling, rehabilitative, or social services as
appropriate (III, GQ, SR)
• OCT imaging when appropriate (III, GQ, SR)
• Refer patients with functionally limiting postoperative
visual impairment for vision rehabilitation (see
www.aao.org/smart-sight-low-vision) and social
services (III, GQ, SR)

Copyright © American Academy of Ophthalmology, November 2015 • www.aao.org 3


Diabetic Retinopathy (Management Recommendations)

Management Recommendations for Patients with Diabetes


Severity of Retinopathy Presence of Follow-up Panretinal Focal and/or Intravitreal Anti-
Macular (Months) Photocoagulation Grid Laser* VEGF Therapy
Edema (Scatter) Laser
Normal or minimal NPDR No 12 No No No
Mild NPDR No 12 No No No
ME 4–6 No No No
CSME† 1* No Sometimes Sometimes
Moderate NPDR No 6–12 No No No
ME 3–6 No No No
CSME† 1* No Sometimes Sometimes
Severe NPDR No 4 Sometimes No No
ME 2–4 Sometimes No No
CSME †
1* Sometimes Sometimes Sometimes
Non-high-risk PDR No 4 Sometimes No No
ME 4 Sometimes No No
CSME †
1* Sometimes Sometimes Sometimes
High-risk PDR No 4 Recommended No Considered
ME 4 Recommended Sometimes Usually
CSME† 1* Recommended Sometimes Usually

Anti-VEGF = anti-vascular endothelial growth factor; CSME = clinically significant macular edema; ME = non-clinically significant
macular edema; NPDR = nonproliferative diabetic retinopathy; PDR = proliferative diabetic retinopathy
* Adjunctive treatments that may be considered include intravitreal corticosteroids or anti-VEGF agents (off-label use, except
aflibercept and ranibizumab). Data from the Diabetic Retinopathy Clinical Research Network in 2011 demonstrated that, at two
years of follow-up, intravitreal ranibizumab with prompt or deferred laser resulted in greater visual acuity gain and intravitreal
triamcinolone acetonide plus laser also resulted in greater visual gain in pseudophakic eyes compared with laser alone. Individuals
receiving the intravitreal injections of anti-VEGF agents may be re-examined as early as one month following injection.
† Exceptions include hypertension or fluid retention associated with heart failure, renal failure, pregnancy, or any other causes that
may aggravate macular edema. Deferral of photocoagulation for a brief period of medical treatment may be considered in these
cases. Also, deferral of CSME treatment is an option when the center of the macula is not involved, visual acuity is excellent, close
follow-up is possible, and the patient understands the risks.

Copyright © American Academy of Ophthalmology, November 2015 • www.aao.org 4

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