Early Photocoagulation for Diabetic Retinopathy : ETDRS

Report Number 9
Early Treatment Diabetic Retinopathy Study Research Group*,
Received 19 July 1990, Accepted 24 January 1991,
Available online 31 October 2013

Abstract
The Early Treatment Diabetic Retinopathy Study (ETDRS) enrolled 3711
patients with mild-to-severe nonproliferative or early proliferative diabetic
retinopathy in both eyes. One eye of each patient was assigned randomly to early
photocoagulation and the other to deferral of photocoagulation. Followup
examinations were scheduled at least every 4 months and photocoagulation was
initiated in eyes assigned to deferral as soon as high-risk proliferative retinopathy
was detected. Eyes selected for early photocoagulation received one of four different
combinations of scatter (panretinal) and focal treatment. This early treatment,
compared with deferral of photocoagulation, was associated with a small reduction in
the incidence of severe visual loss (visual acuity less than 5/200 at two consecutive
visits), but 5-year rates were low in both the early treatment and deferral groups
(2.6% and 3.7%, respectively). Adverse effects of scatter photocoagulation on visual
acuity and visual field also were observed. These adverse effects were most evident
in the months immediately following treatment and were less in eyes assigned to
less extensive scatter photocoagulation. Provided careful follow-up can be
maintained, scatter photocoagulation is not recommended for eyes with mild or
moderate nonproliferative diabetic retinopathy. When retinopathy is more severe,
scatter photocoagulation should be considered and usually should not be delayed if
the eye has reached the high-risk proliferative stage. The ETDRS results
demonstrate that, for eyes with macular edema, focal photocoagulation is
effective in reducing the risk of moderate visual loss but that scatter
photocoagulation is not. Focal treatment also increases the chance of visual
improvement, decreases the frequency of persistent macular edema, and causes
only minor visual field losses. Focal treatment should be considered for eyes with
macular edema that involves or threatens the center of the macula.
Early Treatment Diabetic Retinopathy Study Design
and Baseline Patient Characteristics: ETDRS Report
Number 7
Early Treatment Diabetic Retinopathy Study Research Group . Author links open the
author workspace.*. Numbers and letters correspond to the affiliation list. Click to
expose these in author workspace

Received 19 July 1990, Accepted 24 January 1991, Available online 31 October

2013.

Abstract

The Early Treatment Diabetic Retinopathy Study (ETDRS), a multicenter

collaborative clinical trial supported by the National Eye Institute, was designed to
assess whether argon laser photocoagulation or aspirin treatment can reduce
the risk of visual loss or slow the progression of diabetic retinopathy in
patients with mild-to-severe nonproliferative or early proliferative diabetic
retinopathy. The 3711 patients enrolled in the ETDRS were assigned randomly to
either aspirin (650 mg per day) or placebo. One eye of each patient was assigned
randomly to early argon laser photocoagulation and the other to deferral of
photocoagulation. Both eyes were to be examined at least every 4 months and
photocoagulation was to be initiated in eyes assigned to deferral as soon as high-risk
proliferative retinopathy was detected. Examination of a large number of baseline
ocular and patient characteristics indicated that there were no important
differences between randomized treatment groups at baseline.
 Ophthalmic technology assessment
Single-field fundus photography for diabetic retinopathy
screening : A report by the American Academy of
Ophthalmology
George A Williams, MD,
Ingrid U Scott, MD, MPH,
Julia A Haller, MD,
Albert M Maguire, MD,
Dennis Marcus, MD,
H.Richard McDonald, MD*, , , , , , #
Available online 30 April 2004

Objective

To evaluate whether single-field fundus photography can be used as a

screening tool to identify diabetic retinopathy for referral for further ophthalmic
care.

Methods

A MEDLINE search of the peer-reviewed literature was conducted in June 2001 for
the years 1968 to 2001 and updated in September 2003, yielding 145 articles. The
search was limited to articles published in English. The Cochrane Library of clinical
trials was also investigated. The authors reviewed the abstracts of these articles and
selected 63 of possible clinical relevance for review by the panel. Of these 63
articles, the panel selected 32 for the panel methodologist to review and rate
according to the strength of evidence.

Results

Three of the 32 articles reviewed were classified as level I evidence, and 4 were
classified as level II evidence. Evidence from level I studies demonstrates that as a
tool to detect vision-threatening retinopathy, single-field fundus photography
interpreted by trained readers has sensitivity ranging from 61% to 90% and
specificity ranging from 85% to 97% when compared with the gold standard
reference of stereophotographs of 7 standard fields. When compared with dilated
ophthalmoscopy by an ophthalmologist, single-field fundus photography has
sensitivity ranging from 38% to 100% and specificity ranging from 75% to 100%.
Conclusions

Single-field fundus photography is not a substitute for a comprehensive

ophthalmic examination, but there is level I evidence that it can serve as a
screening tool for diabetic retinopathy to identify patients with retinopathy for
referral for ophthalmic evaluation and management. The advantages of single-
field fundus photography interpreted by trained readers are ease of use (only one
photograph is required), convenience, and ability to detect retinopathy. Further
studies will be required to assess the implementation of single-field photography
based programs to confirm the clinical and cost-effectiveness of these techniques in
improving population visual outcomes. Future research also should include
establishing standardized protocols and satisfactory performance standards for
diabetic retinopathy screening programs.
A comparative evaluation of digital imaging, retinal
photography and optometrist examination in screening for
diabetic retinopathy
Authors

J. A. Olson,F. M. Strachan, J. H. Hipwell,K. A. Goatman,K. C. McHardy,J. V.

Forrester,P. F. Sharp

Abstract

Aims To compare the respective performances of digital retinal imaging, fundus

photography and slit-lamp biomicroscopy performed by trained optometrists, in
screening for diabetic retinopathy. To assess the potential contribution of automated
digital image analysis to a screening programme.

Methods A group of 586 patients recruited from a diabetic clinic underwent three or
four mydriatic screening methods for retinal examination. The respective
performances of digital imaging (n = 586; graded manually), colour slides (n = 586;
graded manually), and slit-lamp examination by specially trained optometrists
(n = 485), were evaluated against a reference standard of slit-lamp biomicroscopy by
ophthalmologists with a special interest in medical retina. The performance of
automated grading of the digital images by computer was also assessed.

Results Slit-lamp examination by optometrists for referable diabetic retinopathy

achieved a sensitivity of 73% (5288) and a specificity of 90% (8793). Using two-
field imaging, manual grading of red-free digital images achieved a sensitivity of 93%
(8298) and a specificity of 87% (8490), and for colour slides, a sensitivity of 96%
(87100) and a specificity of 89% (8691). Almost identical results were achieved for
both methods with single macular field imaging. Digital imaging had a lower technical
failure rate (4.4% of patients) than colour slide photography (11.9%). Applying an
automated grading protocol to the digital images detected any retinopathy, with a
sensitivity of 83% (7789) and a specificity of 71% (6675) and diabetic macular
oedema with a sensitivity of 76% (5392) and a specificity of 85% (8288).

Conclusions Both manual grading methods produced similar results whether using
a one- or two-field protocol. Technical failures rates, and hence need for recall, were
lower with digital imaging. One-field grading of fundus photographs appeared to be
as effective as two-field. The optometrists achieved the lowest sensitivities but
reported no technical failures. Automated grading of retinal images can improve
efficiency of resource utilization in diabetic retinopathy screening.

Diabet. Med. 20, 528534 (2003)