Remote Monitoring of Visual Function in Patients with Maculopathy: The Aphelion Study

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Abstract

Introduction

Remote monitoring of vision, using tools such as the shape discrimination hyperacuity (SDH) test, can detect disease activity in patients with maculopathy. We determined the in-clinic accuracy and repeatability of three myVisionTrack expanded version (mVTx) tests for self-testing of visual acuity (VA) and contrast sensitivity.

Methods

Aphelion, a single-arm, prospective study conducted at two sites in the USA, included adults with any maculopathy and a baseline VA of 0.7 log of minimum angle of resolution (logMAR) (Snellen 20/100) or better. Participants completed the mVTx tests (tumbling E, Landolt C, contrast sensitivity, and SDH) and standard clinical tests (near and distance Early Treatment Diabetic Retinopathy Study [ETDRS] charts and the Pelli–Robson contrast sensitivity chart). Test–retest repeatability and agreement between the mVTx tests and the corresponding clinical test were assessed by Bland–Altman analyses. Participants also completed a usability survey.

Results

The mean age of the 122 participants was 67 years. The most common diagnosis was age-related macular degeneration (42% of patients). The tumbling E test had a test–retest 95% limit of agreement (LoA) of ± 0.18 logMAR; the Landolt C test, ± 0.23 logMAR; the SDH test, ± 0.24 logMAR; and the contrast sensitivity test, ± 0.32 log contrast threshold (logCT). Compared with the distance ETDRS chart, the LoA was ± 0.35 logMAR for the tumbling E test (mean difference, − 0.07 logMAR) and ± 0.39 logMAR for the Landolt C test (mean difference, 0.03 logMAR). For the contrast sensitivity test, the LoA compared with the Pelli–Robson chart was ± 0.30 logCT (mean difference, − 0.25 logCT). Most participants (85%) reported that they learned the tests quickly. The tumbling E test scored the highest on ease of use.

Conclusion

The mVTx tests of VA are accurate and repeatable, supporting their potential use alongside the SDH test to detect disease progression remotely between clinic visits.

Supplementary Information

The online version contains supplementary material available at 10.1007/s40123-023-00854-2.

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Most cited references 51

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STATISTICAL METHODS FOR ASSESSING AGREEMENT BETWEEN TWO METHODS OF CLINICAL MEASUREMENT

J. Martin Bland, DouglasG. Altman (1987)

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Measuring agreement in method comparison studies

J Bland, Douglas G. Altman (2016)

Agreement between two methods of clinical measurement can be quantified using the differences between observations made using the two methods on the same subjects. The 95% limits of agreement, estimated by mean difference +/- 1.96 standard deviation of the differences, provide an interval within which 95% of differences between measurements by the two methods are expected to lie. We describe how graphical methods can be used to investigate the assumptions of the method and we also give confidence intervals. We extend the basic approach to data where there is a relationship between difference and magnitude, both with a simple logarithmic transformation approach and a new, more general, regression approach. We discuss the importance of the repeatability of each method separately and compare an estimate of this to the limits of agreement. We extend the limits of agreement approach to data with repeated measurements, proposing new estimates for equal numbers of replicates by each method on each subject, for unequal numbers of replicates, and for replicated data collected in pairs, where the underlying value of the quantity being measured is changing. Finally, we describe a nonparametric approach to comparing methods.

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Is Open Access

Guidelines for the management of neovascular age-related macular degeneration by the European Society of Retina Specialists (EURETINA)

Ursula Schmidt-Erfurth, Victor Chong, Anat Loewenstein … (2014)

Age-related macular degeneration (AMD) is still referred to as the leading cause of severe and irreversible visual loss world-wide. The disease has a profound effect on quality of life of affected individuals and represents a major socioeconomic challenge for societies due to the exponential increase in life expectancy and environmental risks. Advances in medical research have identified vascular endothelial growth factor (VEGF) as an important pathophysiological player in neovascular AMD and intraocular inhibition of VEGF as one of the most efficient therapies in medicine. The wide introduction of anti-VEGF therapy has led to an overwhelming improvement in the prognosis of patients affected by neovascular AMD, allowing recovery and maintenance of visual function in the vast majority of patients. However, the therapeutic benefit is accompanied by significant economic investments, unresolved medicolegal debates about the use of off-label substances and overwhelming problems in large population management. The burden of disease has turned into a burden of care with a dissociation of scientific advances and real-world clinical performance. Simultaneously, ground-breaking innovations in diagnostic technologies, such as optical coherence tomography, allows unprecedented high-resolution visualisation of disease morphology and provides a promising horizon for early disease detection and efficient therapeutic follow-up. However, definite conclusions from morphologic parameters are still lacking, and valid biomarkers have yet to be identified to provide a practical base for disease management. The European Society of Retina Specialists offers expert guidance for diagnostic and therapeutic management of neovascular AMD supporting healthcare givers and doctors in providing the best state-of-the-art care to their patients. Trial registration number NCT01318941.

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Author and article information

Contributors

Yi-Zhong Wang: yiwang@retinafoundation.org

Journal

Journal ID (nlm-ta): Ophthalmol Ther

Journal ID (iso-abbrev): Ophthalmol Ther

Title: Ophthalmology and Therapy

Publisher: Springer Healthcare (Cheshire )

ISSN (Print): 2193-8245

ISSN (Electronic): 2193-6528

Publication date (Electronic): 28 November 2023

Publication date PMC-release: 28 November 2023

Publication date (Print): January 2024

Volume: 13

Issue: 1

Pages: 409-422

Affiliations

[1 ]Retina Associates, ( https://ror.org/01jc57498) Tucson, AZ USA

[2 ]University of Houston College of Optometry, ( https://ror.org/048sx0r50) Houston, TX USA

[3 ]GRID grid.417570.0, ISNI 0000 0004 0374 1269, F. Hoffmann-La Roche AG, ; Basel, Switzerland

[4 ]GRID grid.419227.b, Roche Products, Ltd., ; Welwyn Garden City, UK

[5 ]Retina Foundation of the Southwest, ( https://ror.org/03sqq2g46) 9600 N. Central Expressway, Suite 200, Dallas, TX 75321 USA

[6 ]GRID grid.267313.2, ISNI 0000 0000 9482 7121, Department of Ophthalmology, , UT Southwestern Medical Center, ; Dallas, TX USA

[7 ]University College London Institute of Ophthalmology, ( https://ror.org/02jx3x895) London, UK

Article

Publisher ID: 854

DOI: 10.1007/s40123-023-00854-2

PMC ID: 10776523

PubMed ID: 38015309

SO-VID: d32b0c95-e700-4e19-8ab3-647948ff2db4

License:

Open Access This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/.

History

Date received : 7 September 2023

Date accepted : 6 November 2023

Funding

Funded by: F. Hoffmann-La Roche AG

Custom metadata

Keywords: contrast sensitivity,hyperacuity,maculopathy,remote monitoring,visual acuity,smartphone application

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Keywords: contrast sensitivity, hyperacuity, maculopathy, remote monitoring, visual acuity, smartphone application

Remote Monitoring of Visual Function in Patients with Maculopathy: The Aphelion Study

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Abstract

Introduction

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Results

Conclusion

Supplementary Information

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Most cited references 51

STATISTICAL METHODS FOR ASSESSING AGREEMENT BETWEEN TWO METHODS OF CLINICAL MEASUREMENT

Measuring agreement in method comparison studies

Guidelines for the management of neovascular age-related macular degeneration by the European Society of Retina Specialists (EURETINA)

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