Evidence map›Paper›PMID 41609020›Full record

Trial reportActa ophthalmologica2026

Mesopic microperimetry in Stargardt disease: Application and reliability.

Sybren H Kootstra, Jeroen A A H Pas, Patty P A Dhooge, Steffen Schmitz-Valckenberg, Maurizio Battaglia Parodi, Philipp Herrmann, Frank G Holz, Andrew J Lotery, Katarina Stingl, Thomas H Wheeler-Schilling and 3 more

Abstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Acta ophthalmologica, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Sybren H KootstraDepartment of Ophthalmology, Radboud University Medical Centre, Nijmegen, GA, The Netherlands.ORCID https://orcid.org/0009-0008-3190-4156
Jeroen A A H PasDepartment of Ophthalmology, Radboud University Medical Centre, Nijmegen, GA, The Netherlands.ORCID https://orcid.org/0000-0002-0302-6690
Patty P A DhoogeDepartment of Ophthalmology, Radboud University Medical Centre, Nijmegen, GA, The Netherlands.ORCID https://orcid.org/0000-0003-1096-1668
Steffen Schmitz-ValckenbergDepartment of Ophthalmology, University of Bonn, Bonn, Germany.
Maurizio Battaglia ParodiDepartment of Ophthalmology, Ospedale San Raffaele, Milan, Italy.
Philipp HerrmannDepartment of Ophthalmology, University of Bonn, Bonn, Germany.
Frank G HolzDepartment of Ophthalmology, University of Bonn, Bonn, Germany.
Andrew J LoteryFaculty of Medicine, University of Southampton, Southampton, UK.
Katarina StinglUniversity Eye Hospital, Centre for Ophthalmology, University of Tübingen, Tübingen, Germany.
Thomas H Wheeler-SchillingUniversity Eye Hospital, Centre for Ophthalmology, University of Tübingen, Tübingen, Germany.
Camiel J F BoonDepartment of Ophthalmology, Amsterdam University Medical Centre, Amsterdam, HV, The Netherlands.ORCID https://orcid.org/0000-0002-6737-7932
Carel B HoyngDepartment of Ophthalmology, Radboud University Medical Centre, Nijmegen, GA, The Netherlands.
Soraprazan Consortium

Funding

European Union's Horizon 2020 research and innovation programme 779317
6 · The paper itself

Abstract

purposeMesopic 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.

methodsOne 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.

resultsMS 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.

conclusionsGiven 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.

Indexed as

Macular DegenerationMesopic VisionStargardt DiseaseVisual AcuityVisual FieldsVisual Field TestsAdolescentAdultFemaleFollow-Up StudiesHumansMaleMiddle AgedProspective StudiesReproducibility of ResultsYoung Adultperimetryretinastargardt diseasetreatment outcomevision tests

Identifiers

PMID41609020
PMCPMC13353732

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.