Evan N Wong1,2, Jehan D A De Soyza2, David A Mackey1, Ian J Constable1,3, Fred K Chen1,2. 1. Centre for Ophthalmology and Visual Science (Lions Eye Institute), The University of Western Australia, Perth, Western Australia, Australia. 2. Department of Ophthalmology, Royal Perth Hospital, Perth, Western Australia, Australia. 3. Department of Ophthalmology, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia.
Abstract
PURPOSE: Microperimetry is used as an endpoint in type 2 macular telangiectasia (mactel) trials. The change required for defining disease progression depends on measurement error. We determined the threshold of test-retest variability (TRV) of microperimetry in mactel. METHODS: A prospective study was done of 24 patients with stable mactel enrolled in a tertiary eye clinic. Each patient underwent three sessions of microperimetry separated by a median of 28 days. An identical testing protocol was used: 4-2 staircase algorithm at 37 loci radial grid covering central 6°. Microperimetry variables were compared across three visits. TRV was quantified by calculating the coefficients of repeatability (CRs) for mean and median foveal sensitivity and the number of loci with dense scotoma (DS) or normal sensitivity (NS). The 95% confidence intervals (CIs) for CRs were calculated. RESULTS: Mean and median foveal sensitivity increased from first to second testing sessions. Test duration, visual acuity, number of loci with DS, and fixation stability remained stable through the three test sessions. The intersession CRs for mean and median foveal sensitivity were 2.6 (95% CI, 1.8-3.3) and 2.4 (95% CI, 1.7-3.1) dB, respectively. CRs for the number of DS and NS loci were 5 and 12 loci. CR for both logBCEA63 and logBCEA95 was 1.0 (95% CI, 0.8-1.2). CONCLUSIONS: The first microperimetry examination should be discarded due to learning effects. TRV in foveal sensitivity may be as high as 3.3 and 3.1 dB (∼0.3 log unit; 2× change) for its mean and median. TRANSLATIONAL RELEVANCE: Our results have implications for the design of clinical trials in mactel.
PURPOSE: Microperimetry is used as an endpoint in type 2 macular telangiectasia (mactel) trials. The change required for defining disease progression depends on measurement error. We determined the threshold of test-retest variability (TRV) of microperimetry in mactel. METHODS: A prospective study was done of 24 patients with stable mactel enrolled in a tertiary eye clinic. Each patient underwent three sessions of microperimetry separated by a median of 28 days. An identical testing protocol was used: 4-2 staircase algorithm at 37 loci radial grid covering central 6°. Microperimetry variables were compared across three visits. TRV was quantified by calculating the coefficients of repeatability (CRs) for mean and median foveal sensitivity and the number of loci with dense scotoma (DS) or normal sensitivity (NS). The 95% confidence intervals (CIs) for CRs were calculated. RESULTS: Mean and median foveal sensitivity increased from first to second testing sessions. Test duration, visual acuity, number of loci with DS, and fixation stability remained stable through the three test sessions. The intersession CRs for mean and median foveal sensitivity were 2.6 (95% CI, 1.8-3.3) and 2.4 (95% CI, 1.7-3.1) dB, respectively. CRs for the number of DS and NS loci were 5 and 12 loci. CR for both logBCEA63 and logBCEA95 was 1.0 (95% CI, 0.8-1.2). CONCLUSIONS: The first microperimetry examination should be discarded due to learning effects. TRV in foveal sensitivity may be as high as 3.3 and 3.1 dB (∼0.3 log unit; 2× change) for its mean and median. TRANSLATIONAL RELEVANCE: Our results have implications for the design of clinical trials in mactel.
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