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Mesopic microperimetry in Stargardt disease: application and reliability

Mesopic microperimetry in Stargardt disease: application and reliability
Mesopic microperimetry in Stargardt disease: application and reliability
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.
1755-375X
Koostra, Sybren H.
7b435e1a-78a1-48fd-b36b-7a63dc217d99
Pas, Jeroen A.A.H.
Dhooge, Patty P.A.
Schmitz-Valckenberg, Steffen
5dcc7e13-e17f-41c4-9bee-401c1744e0cb
Parodi, Maurizio Battaglia
Herrmann, Philipp
23f9d9fe-9ba4-4124-9872-6bd5f0e6e461
Holz, Frank G.
c31bba20-ea0a-4937-ba14-22395fa08f66
Lotery, Andrew J.
5ecc2d2d-d0b4-468f-ad2c-df7156f8e514
Stingl, Katarina
52653c1c-ce76-4108-b5c9-f205f83080f0
Wheeler-Schilling, Thomas H.
Boon, Camiel J.F.
0656f60f-744b-4548-908c-2b9e0aac098f
Hoyng, Carel B.
97ec7551-601c-449e-b539-5a476d56cd5d
Soraprazan Consortium
Koostra, Sybren H.
7b435e1a-78a1-48fd-b36b-7a63dc217d99
Pas, Jeroen A.A.H.
Dhooge, Patty P.A.
Schmitz-Valckenberg, Steffen
5dcc7e13-e17f-41c4-9bee-401c1744e0cb
Parodi, Maurizio Battaglia
Herrmann, Philipp
23f9d9fe-9ba4-4124-9872-6bd5f0e6e461
Holz, Frank G.
c31bba20-ea0a-4937-ba14-22395fa08f66
Lotery, Andrew J.
5ecc2d2d-d0b4-468f-ad2c-df7156f8e514
Stingl, Katarina
52653c1c-ce76-4108-b5c9-f205f83080f0
Wheeler-Schilling, Thomas H.
Boon, Camiel J.F.
0656f60f-744b-4548-908c-2b9e0aac098f
Hoyng, Carel B.
97ec7551-601c-449e-b539-5a476d56cd5d

Koostra, Sybren H., Pas, Jeroen A.A.H., Dhooge, Patty P.A., Schmitz-Valckenberg, Steffen, Parodi, Maurizio Battaglia, Herrmann, Philipp, Holz, Frank G., Lotery, Andrew J., Stingl, Katarina, Wheeler-Schilling, Thomas H., Boon, Camiel J.F. and Hoyng, Carel B. , Soraprazan Consortium (2026) Mesopic microperimetry in Stargardt disease: application and reliability. Acta Ophthalmologica. (doi:10.1111/aos.70072).

Record type: Article

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.

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Accepted/In Press date: 14 January 2026
e-pub ahead of print date: 29 January 2026

Identifiers

Local EPrints ID: 510048
URI: http://eprints.soton.ac.uk/id/eprint/510048
ISSN: 1755-375X
PURE UUID: a2be50c1-4627-4c73-97f0-b29593078768
ORCID for Andrew J. Lotery: ORCID iD orcid.org/0000-0001-5541-4305

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Date deposited: 16 Mar 2026 17:45
Last modified: 17 Mar 2026 02:38

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Contributors

Author: Sybren H. Koostra
Author: Jeroen A.A.H. Pas
Author: Patty P.A. Dhooge
Author: Steffen Schmitz-Valckenberg
Author: Maurizio Battaglia Parodi
Author: Philipp Herrmann
Author: Frank G. Holz
Author: Katarina Stingl
Author: Thomas H. Wheeler-Schilling
Author: Camiel J.F. Boon
Author: Carel B. Hoyng
Corporate Author: Soraprazan Consortium

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