Abstract
OBJECTIVE: Microperimetry is critical for the evaluation of macular light sensitivity, enabling disease monitoring in patients with either center-involving scotoma or initial sparing of the center. The purpose of this study was to investigate the validity and repeatability of light sensitivity measurements with the novel Macular Integrity Assessment (MAIA3) microperimeter compared with the established gold standard MAIA 2013 edition device (MAIA2). DESIGN: A prospective, cross-sectional, premarket clinical investigation on a medical device in a tertiary referral center (ClinicalTrials.gov ID: NCT06071546). PARTICIPANTS: Thirty-four healthy volunteers (median age: 28 years, interquartile range [IQR]: [26-32] years) and 34 patients with retinal pathologies (66 years, IQR: [50.5-74.5] years) were enrolled. All participants underwent comprehensive ophthalmic evaluation, including best-corrected visual acuity testing and OCT imaging. The diagnosis of retinal disease in patients was confirmed through fundoscopy and imaging. MAIN OUTCOME MEASURES: Agreement between MAIA3 and MAIA2 measurements with mean sensitivity (MS) and at the pointwise sensitivity (PWS) level and test-retest (TRT) repeatability of MAIA3 and MAIA2 devices (using Bland-Altman statistics). RESULTS: The bias for the agreement between MAIA3 and MAIA2 measurements was below the established International Organization for Standardization standard of <1 decibel (dB). Healthy participants showed a bias of 0.39 dB for both MS and PWS, 95% confidence interval (CI): 0.11-0.67 dB for MS, 0.30-0.48 dB for PWS. The bias in retinal patients was 0.76 dB (CI: 0.40-1.12 for MS, 0.59-0.93 dB for PWS). The overall bias was 0.57 dB (CI: 0.35-0.80 dB for MS and 0.48-0.67 dB for PWS). Overall TRT repeatability was similar between MAIA3 and MAIA2 devices for MS (Bland-Altman 95% limits of repeatability: -1.16 to 1.53 dB for MAIA3 and -1.49 to 2.06 dB for MAIA2). The examination duration with the MAIA3 device was shorter by 43 seconds compared with the MAIA2 device (median duration: 482.5 seconds [IQR: 451.8-537.5 seconds] for MAIA3 vs. 525.5 seconds [IQR: 500.8-562.3 seconds] for MAIA2). CONCLUSIONS: The MAIA3 microperimetry enables valid and reliable measurements of macular light sensitivity compared with the established device (MAIA2). FINANCIAL DISCLOSURES: Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.