Classification of severity of diabetic retinopathy Lesions present

 Classification of severity of diabetic retinopathy Lesions present

Classification of severity of diabetic retinopathy Lesions present Severity Nonproliferative No retinal lesions No retinopathy No lesions other than microaneurysms

Microaneurysms only Microaneurysms plus retinal hemorrhage,hard exudate ,Mild NPDR,venous loops or both Mild NPDR plus cottonwool spots and/or IRMA Moderate NPDR Presence of one of the following features:microaneurysms plus venous beading and/or H/MA Standard photograph 2A in four quadrants,or marked venous beading in two or

more quadrants, or moderate IRMA(standard photograph 8A in one or more quadrants) Severe NPDR Two or more of the above features described in severe NPDR Very severe NPDR Proliferative New vessels and/or fibrous proliferations;or preretinal and/or vitreous hemorrhage PDR without HRC

NVDstandard photograph 10A;or less extensive NVD,if vitreous or preretinal hemorrhage is present;or NVEhalf disc area,if vitreous or preretinal hemorrhage is present PDR with HRC Extensive vitreous hemorrahage precluding grading,retinal detachment involving the macula,or phthisis bulbi or enucleation secondary to a complication of diabetic retinopathy Advanced PDR SIMPLIFIED CLASSIFICATION OF DIABETIC

RETINOPATHY ln an attempt to improve communication between the ophthalmologists and the primary care physicians caring for patients with diabetes and between clinicians worldwide, a recent international classification of diabetic retinopathy and macular edema was developed. This classification is based on the data collected in the clinical trials and epidemiologic studies of diabetic retinopathy and it simplifies the ETDRS classification of diabetic retinopathy for clinical. With the introduction of this new simplified scale, it is hoped that these systems will be valuable in improving both screening of individuals with diabetes and communication and discussion among individuals caring for these patients.

EPIDEMIOLOGY OF DIABETES AND DIABETIC RETINOPATHY The Centers for Disease Control estimate that 18.2 million American have diabetes and 5.2 million don't know they have it . Type 2 diabetes accounts for up to 95% of aIl diabetes cases ,affecting 8% of the population aged 20 and older. Among the population 60 years and older, 18.6% are affected with diabetes . The prevalence of type 2 diabetes has tripled in the last 30 years , much of it due to an increase in obesity. Among the estimated 10.2 million individuals in the USA older than 40 years of age and with known diabetes, the prevalence

rates of diabetic retinopathy and vision-threatening diabetic retinopathy were 40.3% and 82%, respectively. This translates to 4.1 million adults over the age of 40 years having diabetic retinopathy; one in every 12 known persons with diabetes has severe visionthreatening diabetic retinopathy. Data from population-based studies such as the Wisconsin Epidemiologic Study

of Diabetic Retinopathy (WESDR) provide valuable information regarding both the prevalence and the risk factors associated with the development of diabetic retinopathy. ln the younger-onset group, which consists of patients whose age at diagnosis of diabetes was less than 30 years and who were taking insulin at the time of the examination (presumably those with type 1 diabetes),

retinopathy, either proliferative or nonproliferative, was seen in 13% of patients with less than a 5-year duration of diabetes and in 90% of patients with a duration of 10 to 15 years. PDR, PDR, the the most most vision-threatening vision-threatening form form ofof the the disease,

is present in approximately 25% of disease, is present in approximately 25% of patients patients with with type type 11 diabetes diabetes and and aa 15-year

15-year duration durationofofthe thedisease. disease. For patients with an onset of diabetes at 30 years of age or older (those with type 2 diabetes) and a duration of diabetes less than 5 years, 40% of those taking insulin and 24% of those not taking insulin have retinopathy. These rates increase to 84% and 53%,

respectively, with an increased diabetes duration of 15 to 19 years. PDR develops in 2% of patients with type 2 diabetes and a duration less than 5 years and 25% of patients with a duration of 25 or more years of diabetes. The prevalence of diabetic macular edema did not vary as much by diabetes type. The prevalence of diabetic macular edema is approximately 18% to 20% in patients with either type 1 or type 2 (insulin-taking) diabetes. RISK FACTORS FOR PROGRESSION OF

RETINOPATHY Severity of retinopathy As retinopathy progresses from the mild to moderate to severe and then very severe stages, the risk of developing PDR or visualloss also increases. ln the ETDRS, eyes with very severe NPDR or mild to moderate PDR, or both, had a 60-fold increased risk of developing high-risk PDR after 1 year of follow-up, compared with eyes with mild NPDR (48.5% versus 0.8%). After 5 years of follow-up, there was still a

fivefold increased risk (74.4% versus 14.3%). For patients with bilateral moderate NPDR, the 4-year risk of progression to PDR was increased by 40-fold when compared with patients who had microaneurysms in only one eye. Diabetic retinopathy disease severity scale Proposed disease severity level Finding observable upon dilated ophthalmoscopy No apparent retinopathy No abnormalities

Mild nonproliferative diabetic retinopathy Microaneurysms only Moderate nonproliferative diabetic retinopathy More than just microaneurysms but less than severe nonproliferative diabeticretinopathy Severe nonproliferative diabetic retinopathy : Any of the following More than 20 intraretinal hemorrhages in each of four quadrants Definite venous beading in more than two quadrants Prominent intrartinal microvascular abnormalities in more than one quadrant and no signs of proliferative retinopathy Proliferative diabetic retinopathy :One or more of the following Neovascularization Vitreous/preretinal hemorrhage

Diabetic macular edema disease severity scale Proposed disease severity level Finding observable upon dilated ophthalmoscopy Diabetic macular edema apparently absent No apparent retinal thickening or hard exudates in posterior pole Diabetic macular edema apparently present Some apparent retinal thickening or hard exudates in posterior pole :If diabetic macular edema is present,it can be categorized as follows Proposed disease severity level Finding observable upon dilated ophthalmoscopy Diabetic macular edema present Mild diabetic macular edema Some retinal thickening or hard exudates in posterior pole but distant from the center of the macula Moderate diabetic macular edema

Retinal thickening or hard exudates approaching the center of the macula but not involving the center Severe diabetic macular edema Retinal thickening or hard exudates involving the center of the macula Glycemic control The relationship of glucose control and the chronic complications of diabetes has been extensively studied in observational studies. These studies all demonstrated that increased severity of diabetic retinopathy is associated with poorer glucose contral. Randomized , controlled clinical trials of glycemic

control were designed to address the causal role of glucose control in diabetic complications. ln the Diabetes Control and Complications Trial (DCCT),1441 patients with type 1 diabetes were randomly assigned to either conventional or intensive insulin treatment and followed for a period of 4 to 9 years. Conventional treatment was characterized by one or two daily insulin injections, daily selfmonitoring of urine or blood glucose, and diet and exercise education. Hemoglobin A1c (HbA1c) values were not used to guide treatment, unless an upper limit of 13% was exceeded.

Intensive treatment consisted of insulin administered three or more times daily by injection or an external pump, with dose adjusted according to self-monitored blood glucose results performed at least four times per clay, as weIl as anticipated dietary intake and exercise, and with the goal of lowering HbA1c (measured monthly) to within the nondiabetic range (< 6.05%). The DCCT demonstrated that intensive insulin treatment is associated with a decreased risk of either the development or progression of diabetic retinopathy in patients with type 1 diabetes. In patients without any visible retinopathy when enrolled in the DCCT, the 3-year risk of developing retinopathy was reduced by 75% in the intensive insulin treatment group compared with the standard treatment group. However, ever in the intensively treated group, retinopathy could not be completely prevented over the 9-year course of the study. The benefit of the strict control was also evident in patients with existing retinopathy

(50% reduction in the rate of progression of retinopathy compared with controls). At 6and 12-month visits, a small adverse effect of intensive progression treatment was seen, on retinopathy

similar to that described in other trials of glucose control. However, in eyes with little or no retinopathy at the time of initiating intensive glucose control, this early worsening of retinopathy is unlikely to threaten vision. When the DCCT results were stratified by

hemoglobin A1 C (HbA1 C) levels, there was a 35% to 40% reduction in the risk of retinopathy progression for every 10% decrease in HbA1C (e.g., from 8% to 7.2%). Furthermore, there was a statistically significant reduction in both diabetic neuropathy and nephropathy with intensive blood glucose control in the DCCT. With an additional 7 more years of foIlow-up when the HbA1Cs in both treatment groups were not statistically significant (8.1 % versus 8.2%, P = 0.09),

the rate of progression of retinopathy remained statistically significantly less in those treated with the intensive therapy than in the conventional therapy. The intensive glycemic control over a period of 6.5 years conferred benefits weIl beyond the period of treatment. These data have resulted in recommendations for achieving intense control with HbA1C level below 7% as soon as the diagnosis of diabetes is made. The effect of glycemic control on the

incidence and progression of diabetic retinopathy is similar in patients with type 2 diabetes, as assessed in observational studies and randomized conducted in Japan and the UK. studies

Findings in a study of Japanese patients with type 2 diabetes have shown that multiple insulin-injection treatment reduced the onset of retinopathy from 32% to 8% and reduced a twostep progression retinopathy from 44% to 19%, compared with people receiving conventional insulin treatments over 6 years. ln the UK Prospective Diabetes Study (UKPDS), the largest and longest study of patients with type 2 diabetes, there was a 25% reduction in the risk of the "any diabetes-related microvascular end point," including the need for retinal photocoagulation in the intensive treatment group compared to the

conventional treatment group. After 6 years of follow-up,a smaller proportion of patients in the intensive treatment group than in the conventional group had a two-step progression(worsening) in .diabetic retinopathy(P<0.01). Epidemiologic analysis of the UKPDS data showed a continuous relationship between the risk of microvascular complications and glycemia,so

for every percentage point decrease in HbA1C (e.g., 9% to 8%), there was a 35% reduction in the risk of microvascular complications.

The results of both the DCCT and UKPDS show that, although intensive therapy of glucose does not prevent retinopathy completely , it reduces the risk of the development and progression of diabetic retinopathy. This may be translated clinically to both preservation of vision and reduction in therapy such as laser Photocoagulation. Hypertension The findings of observational studies assessing the importance of blood pressure in the

progressing of NPDR are inconsistent. However, in the UKPDS a randomized comparison of more intensive blood pressure control versus less intensive blood pressure control in persons with type 2 diabetes demonstrated that intensive blood pressure control was associated with a decreased risk of retinopathy progression Tight blood pressure control resulted in a 37% reduction in microvascular diseases, predominantly reduced risk

of retinal photocoagulation, when compared to less tight control. A previously published study of blood pressure medication in diabetic retinopathy suggested that there might be a specific benefit of angiotensin-converting enzyme (ACE) inhibition and blood pressure reduction, even in normotensive persons, on the progression

of diabetic retinopathy. The UKPDS included a randomized comparison of betablockers and ACE inhibitors in the tight blood pressure control arm of that study. Benefits from tight blood pressure control were present in both the betablocker and ACE inhibitor treatment groups, with no statistically significant difference between them. This suggests that the treatment

effect is secondary more to likely blood to

be pressure reduction than to a specific effect of ACE inhibitors. Elevated serum lipid levels The WESDR, a population-based study, and the ETDRS

found that elevated levels of serum cholesterol were associated severity of retinal hard exudate. with increased

ln dependent of the accompanying macular edema, the severity of retinal hard exudate at baseline was associated with decreased visual acuity in the ETDRS. The severity of retinal hard exudate was also a significant risk factor for moderate visual loss (15 letters or more loss) during the course of the study. More recently, the DCCT investigators also evaluated the association of severity of retinopathy and retinal hard exudates with serum lipids. They found that the severity of

retinopathy was associated with increasing triglycerides and inversely associated with lipoprotein cholesterol. high-density The NMR-LSP results showed an increasing severity of retinopathy with small and medium very-lowdensity lipoprotein and inversely with very-lowdensity lipoprotein size. These data support the potential role for dyslipoproteinemia in the

pathogenesis of diabetic retinopathy. Elevated serum triglyceride levels were also associated with a greater risk of developing high-risk PDR in the ETDRS patients. s, e d i r e

c y l g i r t ed t a v e l

e , h g r u sb tt i P n i y

d u t s ln a in e t o r p o p

i l t i y ns e d w o l d e

t a v as well as ele ted i c a o s s a e

b to d n u o f e r e w cholesterol, with PDR.

Although these are all observational findings, the data are compelling to recommend lowering elevated serum lipids in patients with diabetic retinopathy to reduce the risk of visual loss. ln addition to reducing the risk of cardiovascular disease , reducing the risk of visual loss should be another motivating factor for patients to lower elevated serum lipids.

Pregnancy and diabetic retinopathy Diabetic retinopathy may be accelerated during pregnancy because of the pregnancy itself or the changes in metabolic control. ln fact, both the pregnancy and changes in metabolic control may play important roles in accelerating the, progression of diabetic retinopathy. Ideally, patients who are planning to become

pregnant should have their eyes examined before they attempt to conceive and should make every attempt to lower their blood glucose levels to as near normal as possible for the health of the fetus, as well as their own health. During the first trimester, another eye examination should be performed; subsequent follow-up will depend on the findings at the time of this examination. Pregnant women with less than severe NPDR should be examined every 3 months, whereas those with

more severe stages should be seen every 1 to 3 months, as recommended by the American Academy of Ophthalmology Preferred Practice Pattern. Other systemic risk factors Diabetic nephropathy, albuminuria , as

measured by proteinuria ,or renal failure, is found to be a risk factor associated with progression of retinopathy in some, but not aIl, studies. Anemia has also been reported to be associated with progression of

diabetic retinopathy in two small case series and two epidemiologic studies. There was a progressive increase in the risk of development of high-risk PDR with decreasing hematocrit in an adjusted multivariate model in the ETDRS. This may add substantially to the evidence supporting the importance of anemia as a risk factor for diabetic retinopathy.

History of diabetic neuropathy and cardiovascular autonomic neuropathy have also been suggested to be associated with

increased Retinopathy. risk of progression of Eye examination schedule Routine minimum

follow - up Recommended time Time of onset of for first examination diabetes mellitus Annually 5 years after onset Less than 30 years of age Annually

At time of diagnosis Age 30 and older At least every 3 months Before or soon after conception Before pregnancy Recommended follow-up schedule

Status of retinopathy No retinopathy or microaneurysms only Follow-up(months) 12 Mild/moderate NPDR without macular edema 6-12 Mild/moderate NPDR with macular edema that is not clinically significant

4-6 Mild /moderate NPDR with clinically significant macular edema 3-4 Severe/very severe NPDR 3-4 :Diabetes Control and Complication trial rates of progression from nonproliferative diabetic retinopathy

to proliferative diabetic retinopathy and crude relative risks (RRs),by follow-up time period Time period )years( Conventional(C) rate )*cases/person-years( Intensive(I)rate Crude RR,I:C )*cases/person-years( 0-1

(3/351)0.86 (2/362)0.55 0.65 1.5-3 (11/688)1.60 (10/711)1.41

0.88 3.5-5 (12/646)1.86 (6.681)0.88 0.47 5.5-9 (20/504)3.97

(4/580)0.69 0.17 Modified from Diabetes Control and Complications Trial Research Group. The effect of intensive diabetes treatment on the progression of diabetic retinopathy in insulindependent diabetes mellitus. Arch Ophthalmol1995; 113:36-51. *Rates in cases per 100 person-years at risk. Early* worsening(EW) in Diabetes Control and Complications Trial patients assigned to intensive treatment

Clinically important EW CWS/IRMA EW Baseline retinopathy severity No . (%) with EW No . of patients No . (%) with EW No . of patients

(0.0)0 348 (1.1)4 348 No retinopathy (0.0)0

140 (10.0)14 140 MA only , one eye (1.8)2 109 (22.0)24

109 MA only , both eyes (7.3)6 82 (48.3)29 60

Mild NPDR (18.8)6 32 NA NA Moderate NPDR Modified from Diabetes Control and Complications Trial Research Group. Early worsening of

diabetic retinopathy in the diabetes control and complications trial. Arch Ophthalmol1998; 116:874-886.59 CWS, Cottonwool spot; IRMA, intraretinal microvascular abnormalities; MA, microaneurysms; NPDR, nonproliferative diabetic retinopathy. *Within 6 to 12 months of beginning intensive treatment. Cottonwool spots or intraretinal microvascular abnormalities. Development of macular edams or of proliferative diabetic retinopathy or severe NPDR. . .Not applicable; CWS/lRMA at baseline Indications for photocoagulation Treatment should be carried out promptly in most eyes with PDR that have well-established NVD or vitreous or preretinal hemorrhage.

Treatment is particularly urgent when localized fresh vitreous or preretinal hemorrhage is present because of the risk that dispersion of the hemorrhage throughout the vitreous or recurrent bleeding may soon make treatment more difficult or impossible. When visible or suspected new vessels seem insufficient to explain the hemorrhage, special consideration should be given to other possible causes, such as fresh retinal tears, partially avulsed retinal veins, or small patches of new vessels that have been completely avulsed from

the disc or retina. Complete avulsion of a small new vessel patch from its connections to the disc or retina should be considered as a possible explanation of a recent vitreous hemorrhage when the detached posterior vitreous surface can be seen anterior to the disc or retina and contains a subtle opacity, suggesting a small patch of empty new vessels. This occurrence is uncommon, but not rare, and has a good prognosis. Usually no trace can be seen on the disc or retina of the previous new vessel patch and no treatment is necessary.

Progressive contraction of fibrous proliferations leading to displacement or detachment of the macula sometimes follows scatter photocoagulation for high-risk characteristics in eyes with extensive fibrous proliferations. Few such eyes were included in the DRS, but analyses

of them indicated that outcome was better with photocoagulation than without it and suggested that it is only excessively heavy treatment that should be avoided. When high-risk characteristics are definitely present, scatter photocoagulation should usually be carried out, despite the presence of fibrous proliferations or localized

traction retinal detachment. Areas of fibrous proliferations and retinal detachment should be avoided, and treatment strength should be mild to moderate. It may be desirable to divide treatment between several episodes. Of course, photocoagulation is not indicated when PDR

is entering the stage of regression, with few or no new vessels and extensive fibrous proliferations. Extensive neovascularization in the anterior chamber angle is a strong indication for scatter photocoagulation, if it is feasible , regardless of the

presence of high-risk characteristics. Remarkable regression of these new vessels often occurs soon after scatter photocoagulation; if this treatment is carried out before extensive closure of the angle has occurred, full-blown neovascular

glaucoma can be prevented. When opacities of the media preclude retinal photocoagulation, cryoapplications or vitrectomy with endophotocoagulation may be used, with or without additional direct photocoagulation of the new vessels in the anterior chamber angle. The presence of extensive retinal hemorrhage, IRMAs, venous beading, and opaque small arteriolar branches, often accompanied by prominent soft exudates, suggests rapidly progressive closure of the retinal capillary bed and severe

retinal ischemia. New vessels are usually present in such eyes but may be relatively unimpressive . Severe retinal ischemia increases the urgency to initiate scatter photocoagulation, whether or not DRS high-risk characteristics are present, since eyes so affected appear to be at greater risk of anterior segment neovascularization. Patients should be aware of this risk and the risk of a sudden decrease in central vision , which may occur with occlusion of the remaining arterioles supplying the macula. The clinical impression that scatter photocoagulation may precipitate such an occlusion has led to the suggestion that initial scatter

treatment be divided between three or four episodes in the hope of reducing this risk. The ETDRS recommended that scatter, treatment not be used in The ETDRS that NPDR scatter, eyes with mildrecommended to moderate treatment not be used in eyes with mild to but that itNPOR

be but considered for eyes moderate that it be considered for eyes approaching the stage (i.e., eyes approaching thehigh-risk high-risk stage

with very severe NPDR or moderate PDR) and (i.e., very severe or that iteyes usuallywith should not be delayedNPDR when the high-risk stage

present moderate PDR) .and that it isusually should not be delayed when the high-risk stage is present. A policy of continued observation would be expected to spare only a minority of eyes from the risks of treatment, while increasing the risk that rapid progression might occur between follow-up visits and that entry into the high-risk stage might be marked by occurrence of a large vitreous hemorrhage, making satisfactory treatment

difficult. In choosing between prompt treatment and deferral, the commitment of the patient to careful follow-up and the state of the fellow eye are important factors. If visual function decreased in the fellow eye after scatter photocoagulation, deferral of treatment in the second eye may be desirable. On the other band, in a patient whose first eye had an unfortunate outcome without photocoagulation or one with photocoagulation only after PDR was advanced, prompt treatment may be preferable, particularly if close follow-up will be difficult.

These initial ETDRS recommendations were made without regard to patient age or type of diabetes. Subsequent analyses of ETDRS data suggest that, among patients whose retinopathy is in the severe NPDR to non-high-risk PDR range, the benefit of prompt treatment is greater in those who have type 2 diabetes (or are older than 40). In the type 2 group, the 5-year rate of severe visual loss or vitrectomy was about 5% in eyes assigned to early photocoagulation versus 13%

in eyes assigned to deferral, whereas in the type 1 group the rates were about 8% in both treatment groups.

Greater responsiveness to photocoagulation in older versus younger patients has also been observed in other studies. Systemic factors should also be considered in deciding whether to initiate treatment in patients with very severe NPDR or moderate PDR. Clinical impression suggests that

progression of retinopathy may accelerate during or with the development of renal failure. If photocoagulation is deferred until high-risk characteristics develop, and this occurs in the later stages of pregnancy or when renal transplantation or dialysis is required,

these more pressing problems may make it difficult to complete photocoagulation according to a schedule considered optimal from the ophthalmologic point of view. As already mentioned. Scatter photocoagulation and macular edema Macular edema sometimes increases, at least temporarily, after scatter photocoagulation, and this may be followed by transient or persistent reduction of visual acuity.

Both the ETDRS and the DRS support the clinical impression that eyes with macular edema requiring scatter treatment are at less risk of visual acuity loss when focal or grid treatment to reduce the macular edema precedes scatter photocoagulation. If a delay of scatter treatment seems undesirable, the ETDRS protocol can be used, combining focal/grid treatment for macular edema with scatter treatment in the nasal quadrants at the first episode of photocoagulation and adding scatter in the temporal quadrants at one or

more subsequent episodes. Certainly, scatter treatment should not be delayed when the risks of vitreous hemorrhage or neovascular glaucoma seem high, regardless of the status of the macula. Number of episodes used for scatter treatment The new

technique of optical coherence tomography was used in a recent study comparing shorter versus longer spacing between episodes of scatter photocoagulation. Among the techniques currently in use, the number of

episodes in which initial scatter treatment is carried out varies from one to four or more. Those techniques using a smaller number of larger burns tend toward a single episode with retrobulbar anesthesia, whereas those using a larger number of smaller burns nearly always divide treatment into two or more episode. Multiple episodes make it easier to avoid retrobulbar anesthesia and its occasional complications, but they may cause delays and inconvenience for patients who must travel Iong distances for treatment. Angle-closure glaucoma secondary to serous detachment of the peripheral choroid and ciliary body is less common when scatter treatment is

carried out in two or more sessions over a period of 1 or 2 weeks, and some observers believe that small losses in visual acuity may also be less common. Thirty-six patients with severe nonproliferative or early proliferative retinopathy and 20/20 vision in each eye at baseline

received scatter photocoagulation in the following manner: in one eye, one quadrant was treated every week for 4 weeks and in the other eye, one quadrant was treated every other week for 8 weeks. OCT assessment of macular thickness was performed at baseline , before each session of photocoagulation , and at 16 weeks, the end of the follow-up period. Four of 36 eyes in the weekly

treatment group and 3 of 36 in the biweekly group developed center-involved macular edema with decreased visual acuity (from 20/40 to 20/200), which was treated with photocoagulation. At baseline , mean retinal thickness was 191 m in the central zone of the macular grid (1000 m in diameter) in both groups. Thickness increased progressively after each weekly treatment to a maximum of 275 m at week 4 and then decreased to 225 m at 16 weeks. The increase was less after the

biweekly treatments and at 16 weeks was closer to, but had not reached, the baseline value. There was little change in retinal thickness outside the central zone with either treatment technique. The End

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