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Ophthalmology
Original research
Self-Examination Low-Cost Full-Field Optical Coherence Tomography (SELFF-OCT) for neovascular age-related macular degeneration: a cross-sectional diagnostic accuracy study
  1. Claus von der Burchard1,
  2. Helge Sudkamp2,
  3. Jan Tode1,3,
  4. Cristoph Ehlken1,
  5. Konstantine Purtskhvanidze1,
  6. Moritz Moltmann2,
  7. Britta Heimes4,
  8. Peter Koch2,
  9. Michael Münst2,
  10. Malte vom Endt2,
  11. Timo Kepp2,
  12. Dirk Theisen-Kunde2,
  13. Inke König5,
  14. Gereon Hüttmann2,6,
  15. Johann Roider1
  1. 1Department of Ophthalmology, Universitätsklinikum Schleswig-Holstein, Kiel, Germany
  2. 2Medical Laser Center Lübeck GmbH, Lübeck, Germany
  3. 3Department of Ophthalmology, Hannover Medical School, Hannover, Germany
  4. 4Department of Ophthalmology, St. Franziskus-Hospital, Münster, Germany
  5. 5Institute of Medical Biometry and Statistics, University of Lübeck, Lubeck, Germany
  6. 6Institute of Biomedical Optics, University of Lübeck, Lubeck, Germany
  1. Correspondence to Dr Claus von der Burchard; claus.vonderburchard{at}uksh.de

Abstract

Objectives Self-Examination Low-Cost Full-Field Optical Coherence Tomography (SELFF-OCT) is a novel OCT technology that was specifically designed for home monitoring of neovascular age-related macular degeneration (AMD). First clinical findings have been reported before. This trial investigates an improved prototype for patients with AMD and focusses on device operability and diagnostic accuracy compared with established spectral-domain OCT (SD-OCT).

Design Prospective single-arm diagnostic accuracy study.

Setting Tertiary care centre (University Eye Clinic).

Participants 46 patients with age-related macular degeneration.

Interventions Patients received short training in device handling and then performed multiple self-scans with the SELFF-OCT according to a predefined protocol. Additionally, all eyes were examined with standard SD-OCT, performed by medical personnel. All images were graded by at least 2 masked investigators in a reading centre.

Primary outcome measure Rate of successful self-measurements.

Secondary outcome measures Sensitivity and specificity of SELFF-OCT versus SD-OCT for different biomarkers and necessity for antivascular endothelial growth factor (anti-VEGF) treatment.

Results In 86% of all examined eyes, OCT self-acquisition resulted in interpretable retinal OCT volume scans. In these patients, the sensitivity for detection of anti-VEGF treatment necessity was 0.94 (95% CI 0.79 to 0.99) and specificity 0.95 (95% CI 0.82 to 0.99).

Conclusions SELFF-OCT was used successfully for retinal self-examination in most patients, and it could become a valuable tool for retinal home monitoring in the future. Improvements are in progress to reduce device size and to improve handling, image quality and success rates.

Trial registration number DRKS00013755, CIV-17-12-022384.

  • medical retina
  • vetreoretinal
  • ophthalmology

Data availability statement

No data are available. Unfortunately, we cannot share any data other than the data in this manuscript. This is mainly due to the fact that the privacy section in the informed consent that all participants signed does not permit widespread data sharing. Furthermore, raw data might contain patient-specific information.

http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2021-055082

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    Data availability statement

    No data are available. Unfortunately, we cannot share any data other than the data in this manuscript. This is mainly due to the fact that the privacy section in the informed consent that all participants signed does not permit widespread data sharing. Furthermore, raw data might contain patient-specific information.

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    Footnotes

    • Contributors The investigational device and the underlying technology were researched, devised and built by CvdB, HS, MMo, PK, MMü, MvE, TK, DT-K, GH and JR. The study was planned by CvdB, HS, JT, CE, KP, DT-K, IK, GH and JR. All study data were acquired by CvdB. The data were analysed by CvdB, HS, JT, CE, KP, MMo, BH, PK, MMü, TK, DT-K, GH and JR. CB is responsible for the overall content as the guarantor. All of the authors were included in the editing of this paper.

    • Funding The study is supported by Federal Ministry of Education and Research (BMBF) (Grant numbrer: 13N13766).

    • Competing interests HS, PK, MMü and GH hold a patent related to SELFF-OCT. None of the other authors has any conflicts of interest to disclose.

    • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

    • Provenance and peer review Not commissioned; externally peer reviewed.