Safety and Feasibility of a Novel Sparse Optical Coherence Tomography Device for Patient-Delivered Retina Home Monitoring

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Abstract

Purpose

To study a novel and fast optical coherence tomography (OCT) device for home-based monitoring in age-related macular degeneration (AMD) in a small sample yielding sparse OCT (spOCT) data and to compare the device to a commercially available reference device.

Methods

In this prospective study, both eyes of 31 participants with AMD were included. The subjects underwent scanning with an OCT prototype and a spectral-domain OCT to compare the accuracy of the central retinal thickness (CRT) measurements.

Results

Sixty-two eyes in 31 participants (21 females and 10 males) were included. The mean age was 79.6 years (age range, 69–92 years). The mean difference in the CRT measurements between the devices was 4.52 μm (SD ± 20.0 μm; range, −65.6 to 41.5 μm). The inter- and intrarater reliability coefficients of the OCT prototype were both >0.95. The laser power delivered was <0.54 mW for spOCT and <1.4 mW for SDOCT. No adverse events were reported, and the visual acuity before and after the measurements was stable.

Conclusion

This study demonstrated the safety and feasibility of this home-based OCT monitoring under real-life conditions, and it provided evidence for the potential clinical benefit of the device.

Translational Relevance

The newly developed spOCT is a valid and readily available retina scanner. It could be applied as a portable self-measuring OCT system. Its use may facilitate the sustainable monitoring of chronic retinal diseases by providing easily accessible and continuous retinal monitoring.

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Most cited references 38

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Measuring agreement in method comparison studies.

Elliot Bland, Michael Altman (1999)

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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Intravitreal aflibercept injection for neovascular age-related macular degeneration: ninety-six-week results of the VIEW studies.

Ursula Schmidt-Erfurth, Peter K Kaiser, Jean-François Korobelnik … (2014)

To determine efficacy and safety of intravitreal aflibercept in patients with neovascular age-related macular degeneration (AMD) during a second year of variable dosing after a first-year fixed-dosing period. Two randomized, double-masked, active-controlled, phase 3 trials. Two thousand four hundred fifty-seven patients with neovascular AMD. From baseline to week 52, patients received 0.5 mg intravitreal ranibizumab every 4 weeks (Rq4), 2 mg aflibercept every 4 weeks (2q4), 0.5 mg aflibercept every 4 weeks (0.5q4), or 2 mg aflibercept every 8 weeks (2q8) after 3 monthly injections. During weeks 52 through 96, patients received their original dosing assignment using an as-needed regimen with defined retreatment criteria and mandatory dosing at least every 12 weeks. Proportion of eyes at week 96 that maintained best-corrected visual acuity (BCVA; lost <15 letters from baseline); change from baseline in BCVA. Proportions of eyes maintaining BCVA across treatments were 94.4% to 96.1% at week 52 and 91.5% to 92.4% at week 96. Mean BCVA gains were 8.3 to 9.3 letters at week 52 and 6.6 to 7.9 letters at week 96. Proportions of eyes without retinal fluid decreased from week 52 (60.3% to 72.4%) to week 96 (44.6% to 54.4%), and more 2q4 eyes were without fluid at weeks 52 and 96 than Rq4 eyes (difference of 10.4% [95% confidence interval {CI}, 4.9-15.9] and 9.0% [95% CI, 3.0-15.1]). Patients received on average 16.5, 16.0, 16.2, and 11.2 injections over 96 weeks and 4.7, 4.1, 4.6, and 4.2 injections during weeks 52 through 96 in the Rq4, 2q4, 0.5q4, and 2q8 groups, respectively. The number of injections during weeks 52 through 96 was lower in the 2q4 and 2q8 groups versus the Rq4 group (differences of -0.64 [95% CI, -0.89 to -0.40] and -0.55 [95% CI, -0.79 to -0.30]; P < 0.0001, post hoc analysis). Incidences of Antiplatelet Trialists' Collaboration-defined arterial thromboembolic events were similar across groups (2.4% to 3.8%) from baseline to week 96. All aflibercept and ranibizumab groups were equally effective in improving BCVA and preventing BCVA loss at 96 weeks. The 2q8 aflibercept group was similar to ranibizumab in visual acuity outcomes during 96 weeks, but with an average of 5 fewer injections. Small losses at 96 weeks in the visual and anatomic gains seen at 52 weeks in all arms were in the range of losses commonly observed with variable dosing. Copyright © 2014 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

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The economic burden of major adult visual disorders in the United States.

Ping Zhang, Matthew N. McCall, Ronald Klein … (2006)

To estimate the societal economic burden and the governmental budgetary impact of the following visual disorders among US adults aged 40 years and older: visual impairment, blindness, refractive error, age-related macular degeneration, cataracts, diabetic retinopathy, and primary open-angle glaucoma. We estimated 3 components of economic burden: direct medical costs, other direct costs, and productivity losses. We used private insurance and Medicare claims data to estimate direct medical costs; epidemiologic evidence from multiple published sources to estimate other direct costs, such as nursing home costs; and data from the Survey of Income and Program Participation to estimate productivity losses. We used budgetary documents and our direct medical and other direct cost estimates to approximate the governmental budgetary impact. We estimated that the annual total financial burden of major adult visual disorders is $35.4 billion ($16.2 billion in direct medical costs, $11.1 billion in other direct costs, and $8 billion in productivity losses) and that the annual governmental budgetary impact is $13.7 billion. Major visual disorders among Americans older than 40 years result in substantial economic costs for the US economy. Well-designed public health programs may have the ability to reduce this burden in the future.

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Author and article information

Journal

Journal ID (nlm-ta): Transl Vis Sci Technol

Journal ID (iso-abbrev): Transl Vis Sci Technol

Journal ID (hwp): tvst

Journal ID (pmc): Transl Vis Sci Technol

Journal ID (publisher-id): TVST

Title: Translational Vision Science & Technology

Publisher: The Association for Research in Vision and Ophthalmology

ISSN (Electronic): 2164-2591

Publication date Collection: July 2018

Publication date (Electronic): 24 July 2018

Volume: 7

Issue: 4

Electronic Location Identifier: 8

Affiliations

[1 ]OCTlab, Department of Ophthalmology, University Hospital of Basel, Basel, Switzerland

[2 ]University of Zurich, Department of Ophthalmology, University Hospital, Zurich, Switzerland

[3 ]Save Sight Institute, The University of Sydney, Sydney, Australia

[4 ]University of Applied Sciences Engineering and Information Technology, Institute for Human Centered Engineering OptoLab, Biel/Berne, Switzerland

[5 ]Institute of Molecular and Clinical Ophthalmology Basel (IOB), Basel, Switzerland

[6 ]University of Basel, Department of Ophthalmology, Basel, Switzerland

[7 ]Wilmer Eye Institute, Johns Hopkins University, Baltimore, MD, USA

[8 ]Pallas Kliniken AG, Olten, Switzerland

[9 ]Augenklinik der Universität Münster, Münster, Germany

[10 ]Berner Augenklinik am Lindenhofspital and University of Bern, Bern, Switzerland

[11 ]University College London, Institute of Ophthalmology, London, UK

[12 ]Moorfields Ophthalmic Reading Centre, London, UK

[13 ]Moorfields Eye Hospital, London, UK

Author notes

Correspondence: Peter Maloca, Moorfields Eye Hospital, 162 City Road, London EC1V 2PD, London, UK. e-mail: peter.maloca@ 123456moorfields.nhs.uk

Article

Serial Item and Contribution ID: tvst-07-04-08 Publisher ID: TVST-18-0791

DOI: 10.1167/tvst.7.4.8

PMC ID: 6058910

PubMed ID: 30050725

SO-VID: 4c1aa12b-cad3-4a61-a0ad-cb6970fe89ba

License:

This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

History

Date received : 23 March 2018

Date accepted : 6 June 2018

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Safety and Feasibility of a Novel Sparse Optical Coherence Tomography Device for Patient-Delivered Retina Home Monitoring

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Abstract

Purpose

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Related collections

UCL: UN SDG 03 Good Health and Well-Being

Most cited references 38

Measuring agreement in method comparison studies.

Intravitreal aflibercept injection for neovascular age-related macular degeneration: ninety-six-week results of the VIEW studies.

The economic burden of major adult visual disorders in the United States.

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