Stereo nonmydriatic digital-video color retinal imaging compared with Early Treatment Diabetic Retinopathy Study seven standard field 35-mm stereo color photos for determining level of diabetic retinopathy

doi:10.1016/S0161-6420(00)00604-7

Ophthalmology

Volume 108, Issue 3, March 2001, Pages 572-585

Presented in part at the meeting of the American Telemedicine Association, Salt Lake City, Utah, April 1999.

https://doi.org/10.1016/S0161-6420(00)00604-7 Get rights and content

Abstract

Objective

To evaluate the ability to determine clinical levels of diabetic retinopathy, timing of next appropriate retinal evaluation, and necessity of referral to ophthalmology specialists using stereoscopic nonmydriatic digital-video color retinal images as compared with Early Treatment Diabetic Retinopathy Study (ETDRS) seven standard field 35-mm stereoscopic color fundus photographs.

Design

Prospective, clinic-based, comparative instrument validation study.

Participants

Fifty-four patients (108 eyes) with type 1 or type 2 diabetes mellitus selected after chart review from a single center to include the full spectrum of diabetic retinopathy.

Methods

Nonsimultaneous 45°-field stereoscopic digital-video color images (JVN images) were obtained from three fields with the Joslin Vision Network (JVN) system before pupil dilation. Following pupil dilation, ETDRS seven standard field 35-mm stereoscopic color 30° fundus photographs (ETDRS photos) were obtained. Joslin Vision Network images and ETDRS photos were graded on a lesion-by-lesion basis by two independent, masked readers to assess ETDRS clinical level of diabetic retinopathy. An independent ophthalmology retina specialist adjudicated interreader disagreements in a masked fashion.

Main outcome measures

Determination of ETDRS clinical level of diabetic retinopathy, timing of next ophthalmic evaluation of diabetic retinopathy, and need for prompt referral to ophthalmology specialist.

Results

There was substantial agreement (κ = 0.65) between the clinical level of diabetic retinopathy assessed from the undilated JVN images and the dilated ETDRS photos. Agreement was excellent (κ = 0.87) for suggested referral to ophthalmology specialists for eye examinations. Comparison of individual lesions between the JVN images and the ETDRS photos and for interreader comparisons were comparable to the prior ETDRS study.

Conclusions

Undilated digital-video images using the JVN system were comparable photographs for the determination of diabetic retinopathy level. The results validate the agreement between nonmydriatic JVN images and dilated ETDRS photographs and suggest that this digital technique may be an effective telemedicine tool for remotely determining the level of diabetic retinopathy, suggesting timing of next retinal evaluation and identifying the need for prompt referral to ophthalmology specialists. Thus, the JVN system would be an appropriate tool for facilitating increased access of diabetic patients into recommended eye evaluations, but should not be construed as a paradigm that would replace the need for comprehensive eye examinations.

Section snippets

Sample size estimation

A single-center, masked, multireader, inter- and intrareader verified study was performed to evaluate the agreement in assessing severity of diabetic retinopathy at the retinal lesion level between nonmydriatic digital-video retinal imaging (JVN images) using three separate stereoscopic 45° fields and dilated ETDRS stereoscopic seven standard 30° field 35-mm photography (ETDRS photos).

The sample size calculations were determined using a κ evaluation, where κ = 0 defines no correlation and κ = 1

Clinical level of diabetic retinopathy for all eyes

Fifty-four patients (108 eyes) were recruited for this study. For anterior segment evaluations of the undilated video images, four eyes were graded as having media opacities involving the center of the pupil and two eyes were graded as having media opacities not involving the center of the pupil. These gradings were in agreement with findings recorded from the 35-mm dilated anterior segment photography. Additionally, three other eyes, evaluated from the dilated anterior segment photographs,

Discussion

This validation study demonstrates that the determination of clinical level of diabetic retinopathy using the JVN stereoscopic nonmydriatic digital-video color retinal images from three distinct retinal regions obtained using a 45° nonmydriatic camera optimized for low-light–level imaging (JVN images) is in substantial agreement (κ = 0.65) with dilated ETDRS seven standard field 35-mm stereoscopic 30° retinal photography (ETDRS photos). The use of the JVN system, however, does not replace the

Conclusions

This image validation study demonstrates the value of the JVN system for nonmydriatic electronic retinal imaging and the determination of clinical diabetic retinopathy compared with gold standard ETDRS seven standard field 35-mm stereoscopic color 30° fundus photography. The JVN also appropriately identifies the need for prompt referral to specialist ophthalmologists and accurately suggests an appropriate time for repeat ophthalmic examination based on ETDRS-determined risks of progression to

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Effectiveness of Conventional Digital Fundus Photography-Based Teleretinal Screening for Diabetic Retinopathy and Diabetic Macular Edema: A Report by the American Academy of Ophthalmology
2024, Ophthalmology
This American Academy of Ophthalmology Ophthalmic Technology Assessment aims to assess the effectiveness of conventional teleretinal screening (TS) in detecting diabetic retinopathy (DR) and diabetic macular edema (DME).
A literature search of the PubMed database was conducted most recently in July 2023 to identify data published between 2006 and 2023 on any of the following elements related to TS effectiveness: (1) the accuracy of TS in detecting DR or DME compared with traditional ophthalmic screening with dilated fundus examination or 7-standard field Early Treatment Diabetic Retinopathy Study photography, (2) the impact of TS on DR screening compliance rates or other patient behaviors, and (3) cost-effectiveness and patient satisfaction of TS compared with traditional DR screening. Identified studies then were rated based on the Oxford Centre for Evidence-Based Medicine grading system.
Eight level I studies, 14 level II studies, and 2 level III studies were identified in total. Although cross-study comparison is challenging because of differences in reference standards and grading methods, TS demonstrated acceptable sensitivity and good specificity in detecting DR; moderate to good agreement between TS and reference-standard DR grading was observed. Performance of TS was not as robust in detecting DME, although the number of studies evaluating DME specifically was limited. Two level I studies, 5 level II studies, and 1 level III study supported that TS had a positive impact on overall DR screening compliance, even increasing it by more than 2-fold in one study. Studies assessing cost-effectiveness and patient satisfaction were not graded formally, but they generally showed that TS was cost-effective and preferred by patients over traditional surveillance.
Conventional TS is an effective approach to DR screening not only for its accuracy in detecting referable-level disease, but also for improving screening compliance in a cost-effective manner that may be preferred by patients. Further research is needed to elucidate the ideal approach of TS that may involve integration of artificial intelligence or other imaging technologies in the future.
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
Comprehensive Eye Telehealth
2022, Ocular Telehealth: A Practical Guide
This chapter has two major aims—the first is to highlight the most well-known ocular telehealth program, diabetic teleretinal screening, and how this construct can be used for population health management. The second aim discusses comprehensive eye telehealth programs and illustrates some use cases currently available in the United States. In the first section, the deployment of an eye telehealth program for population screening with a major emphasis on diabetes mellitus is discussed. The authors also touch upon the broader implication of other high prevalence diseases such as age-related macular degeneration and glaucoma. The operational guidance of developing a population screening eye telehealth program is emphasized, along with the importance of a collaborative approach involving multiple stakeholders and obtaining “buy-in” from these groups and individual patients. A review of the successful Veteran Affairs (VA) eye telehealth program screening for diabetes is presented as a case study from early ideas to 14 years of existence. The importance and emphasis of information technology personnel collaboration with others are highlighted. The chapter then presents additional use cases for comprehensive ocular exams and screening, many of which are based on the telehealth infrastructure of diabetic teleretinal screening.
The innate immune system in diabetic retinopathy
2021, Progress in Retinal and Eye Research
The prevalence of diabetes has been rising steadily in the past half-century, along with the burden of its associated complications, including diabetic retinopathy (DR). DR is currently the most common cause of vision loss in working-age adults in the United States. Historically, DR has been diagnosed and classified clinically based on what is visible by fundoscopy; that is vasculature alterations. However, recent technological advances have confirmed pathology of the neuroretina prior to any detectable vascular changes. These, coupled with molecular studies, and the positive impact of anti-inflammatory therapeutics in DR patients have highlighted the central involvement of the innate immune system. Reminiscent of the systemic impact of diabetes, immune dysregulation has become increasingly identified as a key element of the pathophysiology of DR by interfering with normal homeostatic systems. This review uses the growing body of literature across various model systems to demonstrate the clear involvement of all three pillars of the immune system: immune-competent cells, mediators, and the complement system. It also demonstrates how the relative contribution of each of these requires more extensive analysis, including in human tissues over the continuum of disease progression. Finally, although this review demonstrates how the complex interactions of the immune system pose many more questions than answers, the intimately connected nature of the three pillars of the immune system may also point to possible new targets to reverse or even halt reverse retinopathy.
Screening for diabetic retinopathy: new perspectives and challenges
2020, The Lancet Diabetes and Endocrinology
Citation Excerpt :
However this procedure is time-consuming and expensive, and thus not appropriate in the screening setting. Therefore, fewer fundus fields (three, two, or even one central field, varying from 45 to 60 degrees) have been proposed for diabetic retinopathy and diabetic macular oedema screening.39–42 Data suggest a sensitivity of 80–98% and specificity of 86–100% for a limited number of fundus fields (two to four) versus seven ETDRS fields for detecting any diabetic retinopathy.
Although the prevalence of all stages of diabetic retinopathy has been declining since 1980 in populations with improved diabetes control, the crude prevalence of visual impairment and blindness caused by diabetic retinopathy worldwide increased between 1990 and 2015, largely because of the increasing prevalence of type 2 diabetes, particularly in low-income and middle-income countries. Screening for diabetic retinopathy is essential to detect referable cases that need timely full ophthalmic examination and treatment to avoid permanent visual loss. In the past few years, personalised screening intervals that take into account several risk factors have been proposed, with good cost-effectiveness ratios. However, resources for nationwide screening programmes are scarce in many countries. New technologies, such as scanning confocal ophthalmology with ultrawide field imaging and handheld mobile devices, teleophthalmology for remote grading, and artificial intelligence for automated detection and classification of diabetic retinopathy, are changing screening strategies and improving cost-effectiveness. Additionally, emerging evidence suggests that retinal imaging could be useful for identifying individuals at risk of cardiovascular disease or cognitive impairment, which could expand the role of diabetic retinopathy screening beyond the prevention of sight-threatening disease.
Comparison of 1-field, 2-fields, and 3-fields fundus photography for detection and grading of diabetic retinopathy
2019, Journal of Diabetes and its Complications
Citation Excerpt :
TRI is cost-effective, screens more patients for DR, and improves access to higher levels of ophthalmologic care.9 Three 45° stereoscopic, NM fields was found to be as effective for DR screening as the Early Treatment Diabetic Retinopathy Study (ETDRS) seven standard fields.10 Fewer fields have been proposed as efficacious for DR screening and are in use due to decreased time and cost.
To evaluate the sensitivity and specificity of 1-, 2-, and 3-fields, nonmydriatic (NM), 45° color photography compared with mydriatic ophthalmoscopy for detection of diabetic retinopathy (DR).
Masked, comparative case series was performed utilizing a group of 128 diabetic patients (256 eyes) with various stages of DR who underwent both 3-fields NM color photography and ophthalmologic examination. In a blinded manner, the same optometrist who read the original 3-fields images for a patient read the 1- and 2-fields photographs on separate dates later.
The sensitivity and specificity of digital retinal photography compared with dilated ophthalmoscopy were, respectively: 88% and 76% for 1-field; 94% and 69% for 2-fields; and 100% and 79% for 3-fields. The proportion of agreement between fundus photography reading and exam DR diagnosis were 58% for 1-field, 58% for 2-fields, and 77% for 3-fields. Kappa and Cramer's V statistics for 1-, 2-, and 3-fields were 0.55 and 0.60, 0.52 and 0.57, and 0.72 and 0.74, respectively. Three-fields measurement of DR was most similar to the dilated ophthalmological exam overall and across all DR severity levels.
Compared to 1- and 2-fields fundus photography, 3-fields is superior for detecting vision-threatening DR. One- and 2-fields have reasonable sensitivity for DR screening.
Accuracy of Detection and Grading of Diabetic Retinopathy and Diabetic Macular Edema Using Teleretinal Screening
2019, Ophthalmology Retina
To determine the accuracy of a county teleretinal screening program of detecting referable diabetic retinopathy (DR) and treatable diabetic macular edema (DME), as well as to evaluate patient compliance with clinic follow-up after referral from teleretinal screening.
Retrospective observational study.
Patients in the Harris Health System (HHS, Houston, TX) older than 18 years of age who underwent teleretinal screening between July 2014 and July 2016.
Teleretinal imaging (TRI) consisting of single-field 45-degree nonmydriatic color fundus photography with referral thresholds of severe nonproliferative DR, proliferative DR, and significant DME. Teleretinal imaging results for all referred subjects were obtained and cross-referenced with dilated fundus examination findings with regard to DR severity and the presence of DME. Follow-up status was also noted. Subjects underwent OCT if deemed necessary by the examining specialist. Agreement between TRI and dilated fundus examination (DFE) findings was determined by calculating the Cohen κ coefficient.
The primary outcome measure is agreement between TRI results and DFE findings with regard to DR severity and the presence of DME. The secondary outcome measure is compliance with follow-up.
Of 1767 patients who were screened and referred for clinical examination, 935 (52.9%) attended their clinic appointment. Overall agreement between DFE and TRI was moderate (weighted κ 0.45) in terms of DR severity. There was agreement within one DR severity level in 86.2% of patients. The positive predictive value for detecting referable disease was 71.3%. Of patients referred for DME, 30.4% were deemed to have treatable DME.
The HHS teleretinal screening program demonstrates a high level of accuracy in the detection and classification of referable DR, but a lesser degree of accuracy in the detection of treatable DME. Only slightly more than half of participants were compliant with follow-up after a TRI referral. This large-scale study provides insight into the utility of teleretinal screening in a county health care system.

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^☆: Supported in part by the Massachusetts Lions Eye Research Fund and from a contract sponsored by the Department of the Army (cooperative agreement no.: DAMD 17-98-2-8017) for the Joslin/Department of Defense (DOD)/Veterans Administration (VA) Program. The content of the information within this program does not necessarily reflect the position or the policy of the government, and no official endorsement should be inferred.

¹: The Joslin Vision Network Research Team consists of Rita Botti; Dahlia K. Bursell, Richard M. Calderon, OD; W. Kelley Gardner, BS; Richard Jackson, MD; Paula Katalinic, B. Optom.; Vincent O’Brien, BS; Philip M. Silver, OD; James Strong, BS; Ann Tolson, BA.

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Stereo nonmydriatic digital-video color retinal imaging compared with Early Treatment Diabetic Retinopathy Study seven standard field 35-mm stereo color photos for determining level of diabetic retinopathy1☆,

Abstract

Objective

Design

Participants

Methods

Main outcome measures

Results

Conclusions

Section snippets

Sample size estimation

Clinical level of diabetic retinopathy for all eyes

Discussion

Conclusions

Ophthalmology

Diabetes Res Clin Pract

Ophthalmology

J Clin Epidemiol

J Clin Epidemiol

J Diabetic Complications

Is diabetes a public-health disorder?

Diabetes Care

Diabetes control programnew directions

Diabetes Educ

Ophthalmic examination among adults with diagnosed diabetes mellitus

JAMA

Cost effectiveness of detecting and treating diabetic retinopathy

Ann Intern Med

Preventive eye care in people with diabetes is cost saving to the federal government. Implications for health-care reform

Diabetes Care

Screening for diabetic retinopathythe utility of nonmydriatic retinal photography in Egyptian adults

Diabet Med

Non-mydriatic fundus photographya viable alternative to fundoscopy for identification of diabetic retinopathy in an Aboriginal population in rural Western Australia?

Aust N Z J Ophthalmol

Screening for diabetic retinopathy using a non-mydriatic retinal camera in rural Victoria

Aust N Z J Ophthalmol

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Diabetes Care

Comparison of non-mydriatic retinal photography with ophthalmoscopy in 2159 patientsmobile retinal camera study

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Instant electronic imaging systems are superior to Polaroid at detecting sight-threatening diabetic retinopathy

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A comparison of digital retinal images and 35 mm colour transparencies in detecting and grading diabetic retinopathy

Diabet Med

Stereo nonmydriatic digital-video color retinal imaging compared with Early Treatment Diabetic Retinopathy Study seven standard field 35-mm stereo color photos for determining level of diabetic retinopathy¹☆,