Reliability of the electronic early treatment diabetic retinopathy study testing protocol in children 7 to <13 years old

doi:10.1016/S0002-9394(03)00388-X

American Journal of Ophthalmology

Volume 136, Issue 4, October 2003, Pages 655-661

https://doi.org/10.1016/S0002-9394(03)00388-X Get rights and content

Abstract

Purpose

To assess the test-retest reliability of the electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity algorithm using the computerized Electronic Visual Acuity (EVA) tester in children 7 to <13 years old.

Design

Test-retest reliability study.

Methods

This multicenter study involved 245 subjects at four clinical sites. As the main outcome measure, visual acuity was measured twice using the E-ETDRS testing protocol on the EVA system, which uses a programmed handheld device to communicate with a personal computer and a 17-inch monitor at a 3-m test distance.

Results

Test–retest reliability was high (r = .94 for right eyes and 0.96 for left eyes) and for both right and left eyes, 89% of retest scores were within 0.1 logarithm of the minimal angle of resolution (logMAR) (five letters) of the initial test score and 99% of retests were within 0.2 logMAR (10 letters). Reliability was high across the age range of 7 to <13 years. Based on 95% confidence level estimates, a change in visual acuity of 0.2 logMAR (10 letters) from a previous acuity measure is unlikely to result from measurement variability.

Conclusions

The E-ETDRS protocol using the EVA has high test–retest reliability in children 7 to <13 years of age. Potential advantages include better standardization across multiple sites, the ability to directly capture data electronically with an automatic acuity score calculation, the reduction of potential bias by limiting the tester’s role, and the requirement of only a single testing distance for measurements from 20/800 to 20/12. This computerized testing method should be considered when visual acuity is used as an outcome measure in eye research involving children 7 to <13 years old.

Section snippets

Methods

The test–retest reliability of the E-ETDRS visual acuity testing was evaluated in 245 subjects at four clinical sites. Subjects were children between 7 and 13 years of age who were being seen as patients at the sites and who agreed to undergo the testing. The study was approved by the respective Institutional Review Boards, and in accordance with the Declaration of Helsinki, informed consent for study participation was obtained from each study subject’s parent or guardian.

Visual acuity was

Results

The baseline characteristics of the 245 subjects are shown in Table 1. The mean age was 9.7 ± 1.7 years. One hundred eleven subjects (45%) were female, 170 (69%) were Caucasian, and 8 (3%) had a developmental delay. There were no subjects who were unable to perform the acuity testing.

One hundred and twenty subjects (49%) were considered to be normal in both eyes. Amblyopia was present in one or both eyes in 40 (16%) subjects, uncorrected refractive error in one or both eyes in 82 (33%), and

Discussion

We found the E-ETDRS visual acuity testing between protocol to have high test-retest reliability in children 7 and 13 years of age. In both the right and left eyes, 89% of the subjects tested within 0.1 logMAR (five letters, equivalent of 1 line) of the initial test score and 99% retested within 0.2 logMAR (10 letters, equivalent of 2 lines) of the first test score. Test–retest reliability was high across the age range of 7 to <13 years old. Among patients with unilateral amblyopia, test–retest

Acknowledgements

The following clinical centers participated in the study: Southern California College of Optometry, Fullerton, California (156 patients): Susan A. Cotter, OD, Raymond H. Chu, OD, Felicia Kang, BS, and Kevin H. Tran, BS; Mayo Clinic, Rochester, Minnesota (66 patients): Jonathan M. Holmes, BM, BCh, and Melissa L. Rice, OD; Columbus Children’s Hospital, Columbus, Ohio (31 patients): Richard W. Hertle, MD, Christopher L. King, COT, and Rebecca A. Murray, COA; Retina Foundation of the Southwest,

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InternetAdvance publication at ajo.com April 29, 2003.

This study was supported by National Eye Institute Grants EY11751 and EY13095.

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Original articleReliability of the electronic early treatment diabetic retinopathy study testing protocol in children 7 to <13 years old☆

Abstract

Purpose

Design

Methods

Results

Conclusions

Section snippets

Methods

Results

Discussion

Acknowledgements

Am J Ophthalmol

Ophthalmology

Ophthal Physiol Opt

Control Clin Trials

Am J Ophthalmol

Am J Ophthalmol

Ophthal Physiol Opt

New design principles for visual acuity letter charts

Am J Optom Physiol Opt

Original article
Reliability of the electronic early treatment diabetic retinopathy study testing protocol in children 7 to <13 years old☆