Establishing Fully-Automated Fundus-Controlled Dark Adaptometry: A Validation and Retest-Reliability Study.

Purpose: The purpose of this study was to establish and validate a novel fundus-controlled dark-adaptometry method. Methods: We developed a custom dark-adaptometry software for the S-MAIA device using the open-perimetry-interface. In the validation-substudy, participants underwent dark-adaptometry testing with a comparator device (MonCvONE, 59% rhodopsin bleach, cyan and red stimuli centered at 2 degrees, 4 degrees, and 6 degrees eccentricity). Following a brief break (approximately 5 minutes), the participants were bleached again and underwent dark-adaptometry testing with the S-MAIA device (same loci). In the retest reliability-substudy, participants were tested twice with the S-MAIA device (same loci as above). Nonlinear curve fitting was applied to extract dark-adaptation curve parameters. Validity and repeatability were summarized in terms of the mean bias and 95% limits of agreement (LoAs). Results: In the validation-substudy (N = 20 participants, median age interquartile range [IQR] 31.5 years [IQR = 25.8, 62.0]), measures of rod-mediated dark-adaptation showed little to no between method differences for the cone-rod-break-time (bias 95% confidence interval [95% CI] of +0.1 minutes [95% CI = -0.6 to 0.8]), rod-intercept-time (-0.23 minutes [95% CI = -1.38 to 0.93]), and S2 slope (-0.01 LogUnits/minutes [95% CI = -0.02 to -0.01]). In the retest reliability-substudy (N = 10 participants, 32.0 years [95% CI = 27.0, 57.5]), the corresponding LoAs were (cone-rod-break-time) -3.94 to 2.78 minutes, (rod-intercept-time) -4.55 to 3.11 minutes, and (S2 slope [rate-limited component of rod recovery]) -0.03 to 0.03 LogUnits/minutes. The LoAs for the steady-state cone and rod thresholds were -0.28 to 0.33 LogUnits and -0.34 to 0.28 LogUnits. Conclusions: The devised fundus-controlled dark-adaptometry method yields valid and reliable results. Translational Relevance: Fundus-controlled dark-adaptometry solves the critical need for localized testing of the visual cycle and retinoid transfer in eyes with unstable fixation.