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      Evaluation of a self-imaging SD-OCT system designed for remote home monitoring

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          Abstract

          Purpose

          To compare identification rates of retinal fluid of the Notal Vision Home Optical Coherence Tomography (OCT) device (NVHO) when used by people with age-related macular degeneration (AMD) to those captured by a commercial OCT.

          Methods

          Prospective, cross-sectional study where patients underwent commercial OCT imaging followed by self-imaging with either the NVHO 2.5 or the NVHO 3 in clinic setting. Outcomes included patients’ ability to acquire analyzable OCT images with the NVHO and to compare those with commercial images.

          Results

          Successful images were acquired with the NVHO 2.5 in 469/531 eyes (88%) in 264/290 subjects (91%) with the mean (SD) age of 78.8 (8.8); 153 (58%) were female with median visual acuity (VA) of 20/40. In the NVHO 3 cohort, 69 eyes of 45 subjects (93%) completed the self-imaging. Higher rates of successful imaging were found in eyes with VA ≥ 20/320. Positive percent agreement/negative percent agreement for detecting the presence of subretinal and/or intraretinal fluid when reviewing for fluid in three repeated volume scans were 97%/95%, respectively for the NVHO v3.

          Conclusion

          Self-testing with the NVHO can produce high quality images suitable for fluid identification by human graders, suggesting the device may be able to complement standard-of-care clinical assessments and treatments.

          Supplementary Information

          The online version contains supplementary material available at 10.1186/s12886-022-02458-z.

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          Most cited references14

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          Ranibizumab for neovascular age-related macular degeneration.

          Philip J. Rosenfeld, David M Brown, Jeffrey Heier … (2006)
          Ranibizumab--a recombinant, humanized, monoclonal antibody Fab that neutralizes all active forms of vascular endothelial growth factor A--has been evaluated for the treatment of neovascular age-related macular degeneration. In this multicenter, 2-year, double-blind, sham-controlled study, we randomly assigned patients with age-related macular degeneration with either minimally classic or occult (with no classic lesions) choroidal neovascularization to receive 24 monthly intravitreal injections of ranibizumab (either 0.3 mg or 0.5 mg) or sham injections. The primary end point was the proportion of patients losing fewer than 15 letters from baseline visual acuity at 12 months. We enrolled 716 patients in the study. At 12 months, 94.5% of the group given 0.3 mg of ranibizumab and 94.6% of those given 0.5 mg lost fewer than 15 letters, as compared with 62.2% of patients receiving sham injections (P<0.001 for both comparisons). Visual acuity improved by 15 or more letters in 24.8% of the 0.3-mg group and 33.8% of the 0.5-mg group, as compared with 5.0% of the sham-injection group (P<0.001 for both doses). Mean increases in visual acuity were 6.5 letters in the 0.3-mg group and 7.2 letters in the 0.5-mg group, as compared with a decrease of 10.4 letters in the sham-injection group (P<0.001 for both comparisons). The benefit in visual acuity was maintained at 24 months. During 24 months, presumed endophthalmitis was identified in five patients (1.0%) and serious uveitis in six patients (1.3%) given ranibizumab. Intravitreal administration of ranibizumab for 2 years prevented vision loss and improved mean visual acuity, with low rates of serious adverse events, in patients with minimally classic or occult (with no classic lesions) choroidal neovascularization secondary to age-related macular degeneration. (ClinicalTrials.gov number, NCT00056836 [ClinicalTrials.gov].). Copyright 2006 Massachusetts Medical Society.
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            Age-related macular degeneration.

            Laurence Lim, Paul Mitchell, Johanna Seddon … (2012)
            Age-related macular degeneration is a major cause of blindness worldwide. With ageing populations in many countries, more than 20% might have the disorder. Advanced age-related macular degeneration, including neovascular age-related macular degeneration (wet) and geographic atrophy (late dry), is associated with substantial, progressive visual impairment. Major risk factors include cigarette smoking, nutritional factors, cardiovascular diseases, and genetic markers, including genes regulating complement, lipid, angiogenic, and extracellular matrix pathways. Some studies have suggested a declining prevalence of age-related macular degeneration, perhaps due to reduced exposure to modifiable risk factors. Accurate diagnosis combines clinical examination and investigations, including retinal photography, angiography, and optical coherence tomography. Dietary anti-oxidant supplementation slows progression of the disease. Treatment for neovascular age-related macular degeneration incorporates intraocular injections of anti-VEGF agents, occasionally combined with other modalities. Evidence suggests that two commonly used anti-VEGF therapies, ranibizumab and bevacizumab, have similar efficacy, but possible differences in systemic safety are difficult to assess. Future treatments include inhibition of other angiogenic factors, and regenerative and topical therapies. Copyright © 2012 Elsevier Ltd. All rights reserved.
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              HAWK and HARRIER: phase 3, multicenter, randomized, double-masked trials of brolucizumab for neovascular age-related macular degeneration

              Pravin Dugel, Adrian Koh, Yuichiro Ogura … (2019)
              Two similarly designed phase 3 trials (HAWK and HARRIER) compared brolucizumab, a single-chain antibody fragment that inhibits vascular endothelial growth factor-A, with aflibercept to treat neovascular age-related macular degeneration (nAMD).
              Article 0 comments Cited 270 times – based on 0 reviews     Review now
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                Author and article information

                Contributors
                Judy E. Kim: jekim@mcw.edu
                Oren Tomkins-Netzer: oren.tomkins@gmail.com
                Michael J. Elman: elman@elmanretina.com
                David R. Lally: david.lally@neretina.com
                Michaella Goldstein: michaellag@tlvmc.gov.il
                Dafna Goldenberg: dafnagoldenberg@gmail.com
                Shiri Shulman: shirishu@assuta.co.il
                Gidi Benyamini: gidi@notalvision.com
                Anat Loewenstein: anatl@tlvmc.gov.il
                Journal
                Journal ID (nlm-ta): BMC Ophthalmol
                Journal ID (iso-abbrev): BMC Ophthalmol
                Title: BMC Ophthalmology
                Publisher: BioMed Central (London )
                ISSN (Electronic): 1471-2415
                Publication date (Electronic): 10 June 2022
                Publication date PMC-release: 10 June 2022
                Publication date Collection: 2022
                Volume: 22
                Electronic Location Identifier: 261
                Affiliations
                [1 ]GRID grid.30760.32, ISNI 0000 0001 2111 8460, The Eye Institute, Medical College of Wisconsin, ; 925 N. 87th street, Milwaukee, WI 53226 USA
                [2 ]GRID grid.413469.d, Department of Ophthalmology, , Lady Davis Carmel Medical Center, Ruth and Bruce Rappaport Faculty of Medicine, ; Technion, Haifa, Israel
                [3 ]GRID grid.512014.3, Elman Retina Group PA, ; Baltimore, MD USA
                [4 ]Retina Research Institute at New England Retina Consultants, Springfield, MA USA
                [5 ]GRID grid.413449.f, ISNI 0000 0001 0518 6922, Tel Aviv Medical Center, ; Tel Aviv, Israel
                [6 ]GRID grid.414003.2, ISNI 0000 0004 0644 9941, Assuta Medical Centers, ; Tel Aviv, Israel
                [7 ]GRID grid.511740.6, ISNI 0000 0004 6011 187X, Notal Vision, ; Tel Aviv, Israel
                Article
                Publisher ID: 2458
                DOI: 10.1186/s12886-022-02458-z
                PMC ID: 9186475
                PubMed ID: 35689210
                SO-VID: dde16a9e-e1de-4f31-9ceb-5a0d20d36586
                Copyright © © The Author(s) 2022
                License:

                Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits 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/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

                History
                Date received : 28 October 2021
                Date accepted : 16 May 2022
                Funding
                Funded by: Notal Vision
                Categories
                Subject: Research
                Custom metadata
                issue-copyright-statement © The Author(s) 2022

                ScienceOpen disciplines: Ophthalmology & Optometry
                Keywords: age-related macular degeneration,home oct,home monitoring
                Data availability:
                ScienceOpen disciplines: Ophthalmology & Optometry
                Keywords: age-related macular degeneration, home oct, home monitoring

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