The purpose of this pre-market, monocentric cross-sectional study is to evaluate the clinical usefulness of a new version of the MAIA device (MAIA) through an agreement with the established version of the MAIA microperimeter (MAIA 2013 EDITION). Moreover, the study aims to evaluate MAIA test-retest repeatability in comparison with MAIA 2013 EDITION and to evaluate MAIA safety and adverse events. These purposes will be achieved by collecting data of healthy subjects and patients with retinal pathology. All participants will undergo repeated microperimetric examinations with both devices during one single visit.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
68
MAIA is a visual field testing device combining visual field tests, fixation loss correction by a real-time retinal tracker and confocal TrueColor fundus imaging (P/N AHMACME001)
Universitätsspital Basel, Augenklinik
Basel, Switzerland
To evaluate the limits of agreement between MAIA and MAIA 2013 EDITION for threshold sensitivity values.
Agreement will be quantified by using the method proposed by Bland and Altman \[1,2,3\], estimating the 95%-Limits of Agreement (LoA) of the difference of threshold sensitivity values. The acceptance criteria for agreement between MAIA and MAIA 2013 EDITION is that MAIA's 95% LoA limits are within MAIA 2013 EDITION repeatability limits. 1. Bland JM, Altman DG (1986) Statistical methods for assessing agreement between two methods of clinical measurement. Lancet 1(8476):307-10. 2. Bland JM, Altman DG (1999) Measuring agreement in method comparison studies. Statistical Methods in Medical Research 8:135-160 3. Bland JM, Altman DG (2007), Agreement Between Methods of Measurement with Multiple Observations Per Individual, Journal of Biopharmaceutical Statistics 17:571-82
Time frame: 1 day
To assess the repeatability limits of retinal threshold sensitivity values obtained with MAIA
The acceptance criteria is that the 95% LoA limits for MAIA are at least as narrow as MAIA 2013 EDITION repeatability limits.
Time frame: 1 day
To assess the avoidance of Serious Adverse Device Effects with MAIA
During the clinical investigation, adverse events will be documented, investigated and reported according to the provisions of applicable reporting guidelines, following their criteria and timelines
Time frame: through study completion (expected duration: 3 months)
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