Mesopic microperimetry in Stargardt disease: Application and reliability
Acta Ophthalmologica, vol. 104, pp. e544–e554
Abstract
PURPOSE: Mesopic microperimetry (mMP) is a promising functional endpoint in clinical trials for Stargardt disease type 1 (STGD1). This study evaluated the test-retest variability of mMP and influencing factors, which is essential for ensuring reliability in future STGD1 trials. METHODS: One hundred and fifteen eyes from 68 patients enrolled in the prospective, tertiary, multicentre STArgardt Remofuscin Treatment Trial (STARTT) underwent mMP testing using the macular integrity assessment (MAIA) microperimeter (CenterVue, Padova, Italy) at both the screening (first) and baseline (second) visits of the trial. Test-retest variability was assessed using Bland-Altman analyses and coefficients of repeatability (CoR). Retinal sensitivity metrics included mean sensitivity (MS) and pointwise sensitivity (PWS). Other factors including fixation stability, exam duration and learning effect were analysed. RESULTS: MS demonstrated the lowest variability (CoR: 3.53 dB, 95% CI: 3.07-3.99), while PWS exhibited the highest (CoR: 12.69 dB, 95% CI: 12.47-12.91). Variability decreased in sensitivity ranges from -1 to 3 dB and 16 to 32 dB and from central to peripheral regions. Test duration (Spearman's ρ = 0.609, p < 0.001) and fixation losses (Spearman's ρ = 0.284, p = 0.003) were significantly associated with increased variability. Other fixation stability metrics showed no correlation. No learning effect was observed. CONCLUSIONS: Given its high variability, PWS should be used cautiously. MS offers lower variability but may mask localised functional changes. A parafoveal ring strategy may improve reliability but requires validation. Limiting test duration to ≤450 seconds and comprehensive operator training are recommended to minimise potential bias.
Authors 12
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Radboud University Nijmegen · Radboud University Medical Center
Affiliation as printed
Department of Ophthalmology Radboud University Medical Centre Nijmegen GA The Netherlands
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Radboud University Nijmegen · Radboud University Medical Center · Donders Institute for Brain, Cognition and Behaviour
Affiliation as printed
Department of Ophthalmology Radboud University Medical Centre Nijmegen GA The Netherlands
Donders Institute for Brain, Cognition and Behaviour Radboud University Nijmegen EN The Netherlands
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Radboud University Nijmegen · Radboud University Medical Center
Affiliation as printed
Department of Ophthalmology Radboud University Medical Centre Nijmegen GA The Netherlands
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University of Bonn · University of Utah
Affiliation as printed
Department of Ophthalmology University of Bonn Bonn Germany
GRADE Reading Centre Bonn Germany
John A. Moran Eye Centre University of Utah Salt Lake City Utah USA
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Affiliation as printed
Department of Ophthalmology Ospedale San Raffaele Milan Italy
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Affiliation as printed
Centre for Rare Diseases Bonn (ZSEB) University of Bonn Bonn Germany
Department of Ophthalmology University of Bonn Bonn Germany
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Affiliation as printed
Department of Ophthalmology University of Bonn Bonn Germany
GRADE Reading Centre Bonn Germany
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Affiliation as printed
Faculty of Medicine University of Southampton Southampton UK
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Universitätsklinikum Tübingen · University of Tübingen
Affiliation as printed
Centre for Rare Eye Diseases University of Tübingen Tübingen Germany
University Eye Hospital, Centre for Ophthalmology University of Tübingen Tübingen Germany
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Universitätsklinikum Tübingen · University of Tübingen
Affiliation as printed
University Eye Hospital, Centre for Ophthalmology University of Tübingen Tübingen Germany
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Camiel J. F. Boon Aachen Department of Ophthalmology Leiden University Medical Centre Leiden ZA The Netherlands
Leiden University · Leiden University Medical Center · Amsterdam University Medical Centers
Affiliation as printed
Department of Ophthalmology Amsterdam University Medical Centre Amsterdam HV The Netherlands
Department of Ophthalmology Leiden University Medical Centre Leiden ZA The Netherlands
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C. B. Hoyng corresponding
Radboud University Nijmegen · Radboud University Medical Center · Donders Institute for Brain, Cognition and Behaviour
Affiliation as printed
Department of Ophthalmology Radboud University Medical Centre Nijmegen GA The Netherlands
Donders Institute for Brain, Cognition and Behaviour Radboud University Nijmegen EN The Netherlands
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