Karuntu Jessica S, Pfau Maximilian, Jolly Jasleen K, Boon Camiel J F
Department of Ophthalmology, Leiden University Medical Center, Leiden, The Netherlands.
Institute of Molecular and Clinical Ophthalmology Basel, Basel, Switzerland.
Acta Ophthalmol. 2025 May;103(3):313-326. doi: 10.1111/aos.16780. Epub 2024 Nov 24.
Understanding test-retest variability (TRV) of mesopic microperimetry is critical for defining meaningful treatment effects in retinitis pigmentosa (RP) trials. This study uniquely evaluates intra- and intervisit TRV and coefficients of repeatability (CoRs) for microperimetry parameters in RP patients with varying best-corrected visual acuity (BCVA) levels.
In this single-centre prospective cohort study, RP patients were assessed on two visits, 14.0 days apart. Patients were grouped by BCVA: low (≤20/50 Snellen; ≥0.4 logMAR) or moderate (>20/50 Snellen; <0.4 logMAR). Using Bland-Altman analyses, the CoRs for intra- and intervisit variability were determined for pointwise (dB), mean (dB), and volume sensitivity (dB*deg) on mesopic microperimetry.
Intravisit CoRs for mean, volume, and pointwise sensitivity were 1.7 dB, 353.2 dBdeg, and 8.6 dB, respectively, in the low-BCVA group (n = 32), and 0.9 dB, 254.5 dBdeg, and 7.3 dB in the moderate-BCVA group (n = 15). Intervisit CoRs for mean, volume, and pointwise sensitivity were 2.4 dB, 355.2 dBdeg, and 10.2 dB in the low-BCVA group (n = 31). The moderate-BCVA group (n = 16) showed smaller CoRs of 1.6 dB, 386.8 dBdeg, and 7.7 dB for mean, volume, and pointwise sensitivity. BCVA and mean sensitivity, but not fixation stability, are predictors of TRV for volume sensitivity.
Due to significant TRV, pointwise sensitivity is an unreliable endpoint for RP patients, irrespective of BCVA. Mean sensitivity is suitable as an endpoint when BCVA is relatively preserved. Volume sensitivity provides additional spatial information, and shows promise as a clinical endpoint for assessing macular sensitivity changes on mesopic microperimetry in patients with RP.
了解中视微视野检查的重测变异性（TRV）对于在视网膜色素变性（RP）试验中定义有意义的治疗效果至关重要。本研究独特地评估了不同最佳矫正视力（BCVA）水平的RP患者微视野检查参数的访内和访间TRV以及重复性系数（CoRs）。
在这项单中心前瞻性队列研究中，对RP患者进行了两次评估，间隔14.0天。患者按BCVA分组：低视力（≤20/50 Snellen；≥0.4 logMAR）或中度视力（>20/50 Snellen；<0.4 logMAR）。使用Bland-Altman分析，确定中视微视野检查中逐点（dB）、平均（dB）和体积敏感度（dB*deg）的访内和访间变异性的CoRs。
低视力组（n = 32）平均、体积和逐点敏感度的访内CoRs分别为1.7 dB、353.2 dBdeg和8.6 dB，中度视力组（n = 15）分别为0.9 dB、254.5 dBdeg和7.3 dB。低视力组（n = 31）平均、体积和逐点敏感度的访间CoRs分别为2.4 dB、355.2 dBdeg和10.2 dB。中度视力组（n = 16）平均、体积和逐点敏感度的CoRs较小，分别为1.6 dB、386.8 dBdeg和7.7 dB。BCVA和平均敏感度是体积敏感度TRV的预测因素，但注视稳定性不是。
由于显著的TRV，无论BCVA如何，逐点敏感度对于RP患者来说都是不可靠的终点。当BCVA相对保留时，平均敏感度适合作为终点。体积敏感度提供了额外的空间信息，并有望作为评估RP患者中视微视野检查黄斑敏感度变化的临床终点。
