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Published on: May 25, 2020
Validation of a self-administered Home ETDRS visual acuity testing (H-ETDRS) for self-monitoring vision changes in
Zitian Liu1, Yanjing Huang2, Ling Jin2
1State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Guangdong Provincial Key Laboratory of Ophthalmology and Visual Science, Guangdong Provincial Clinical Research Center for Ocular Diseases, Sun Yat-Sen University, Guangzhou, Guangdong, China liuzt25@mail.sysu.edu.cn.
Objective:
To validate a self-administered Home Early Treatment Diabetic Retinopathy Study (H-ETDRS) visual acuity (VA) test and to assess its accuracy in detecting VA decline in patients with retinal diseases.
Methods:
A validation group of 156 participants and a testing group of 100 participants with diabetic retinopathy and age-related macular degeneration were recruited. All participants underwent monocular distance best-corrected VA (BCVA) tests in the study eye using the standard ETDRS (S-ETDRS) charts in clinic and the H-ETDRS device in a simulated home setting. Participants in the validation group repeated both methods. H-ETDRS letter scores were compared with S-ETDRS scores, evaluating mean difference and test-retest reliability (TRR). Intraclass correlation coefficients (ICCs) were calculated to measure the agreement. Participants in the testing group repeated both methods with a Bangerter filter density of 0.6 to simulate BCVA change. The performance of H-ETDRS in detecting acuity change was evaluated, with S-ETDRS serving as the standard.
Results:
For the validation group, the mean difference between S-ETDRS and H-ETDRS scores was -1.38 letters (95% limits of agreement (LOA) -6.99 to 4.22). The scores of the two tests were highly correlated with an ICC of 0.98. The mean differences between initial test and retest scores were 0.11 letters (95% LOA -2.62 to 2.84) for S-ETDRS and -0.13 letters (95% LOA -5.64 to 5.38) for H-ETDRS. The ICCs of test-retest letter scores were 1.00 for S-ETDRS and 0.98 for H-ETDRS. For participants in the testing group who showed BCVA decline of one line or more with Bangerter filter, 96.7% were able to detect VA changes using H-ETDRS.
Conclusions And Relevance:
The H-ETDRS test demonstrates high TRR and good concordance with S-ETDRS test for retinal patients. The H-ETDRS is viable for self-monitoring VA changes in retinal diseases, however, further validation studies in actual home settings are warranted.
