Control of myopia using diffusion optics spectacle lenses:4-year results of a multicentre randomised controlled, efficacy and safety study (CYPRESS)

Abstract

AIMS: To evaluate the myopia control efficacy of Diffusion Optics Technology (DOT) spectacle lenses in children over a 4-year treatment period. METHODS: CYPRESS Part 1 (NCT03623074) was a 3-year multicentre, randomised, controlled, double-masked trial comparing two investigational spectacle lens DOT designs (Test 1, Test 2) and standard single vision Control lenses in 256 North American children aged 6-10 years. Children completing Part 1 (n=200) were invited to enrol in CYPRESS Part 2 (NCT04947735) for an additional 1-year period. In Part 2, Test 1 (n=35) and Control groups (n=42) continued with their original lens assignment and the Test 2 group (n=21) were crossed over to Test 1 (DOT 0.2) lenses. The co-primary endpoints were change from baseline in axial length (AL) and cycloplegic spherical equivalent refraction (cSER). RESULTS: Test 1 spectacle lenses demonstrated superiority to the Control in both co-primary endpoints: with a difference between means (Test 1-Control) of -0.13 mm for AL (p=0.018) and 0.33 D for cSER (p=0.008) in Part 1 and -0.05 mm for AL (p=0.038) and 0.13 D for cSER (p=0.043) in Part 2. Comparing treatment effects in Part 1 and 2 suggests that COVID-19 public health restrictions negatively impacted treatment efficacy in study years 2 and 3. CONCLUSION: DOT 0.2 spectacle lenses are safe and effective at reducing myopia progression, with additional benefit evident in year 4 of wear. These results support the hypothesis that a mild reduction in retinal contrast can slow myopia progression in young children. The unprecedented disruption in participant schooling and lifestyle during the COVID-19 pandemic may have depressed treatment efficacy in Part 1.

Publication DOI: https://doi.org/10.1136/bmjophth-2024-001790
Divisions: College of Health & Life Sciences
College of Health & Life Sciences > School of Optometry > Optometry & Vision Science Research Group (OVSRG)
College of Health & Life Sciences > School of Optometry > Optometry
Aston University (General)
Funding Information: This study received support from SightGlass Vision, Texas, USA, which produced and provided the investigational products.
Additional Information: Copyright © Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. 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: https://creativecommons.org/licenses/by-nc/4.0/
Publication ISSN: 2397-3269
Last Modified: 21 Nov 2024 17:43
Date Deposited: 30 Oct 2024 18:06
Full Text Link:
Related URLs: https://bmjopht ... ent/9/1/e001790 (Publisher URL)
http://www.scop ... tnerID=8YFLogxK (Scopus URL)
PURE Output Type: Article
Published Date: 2024-10-09
Published Online Date: 2024-10-09
Accepted Date: 2024-09-29
Authors: Laughton, Deborah
Hill, Jennifer S.
McParland, Marcella
Tasso, Vanessa
Woods, Jill
Zhu, Xiaoying
Young, Graeme
Craven, Ruth
Hunt, Chris
Neitz, Jay
Neitz, Maureen
Chalberg, Thomas W.
Jones, Deborah
Wolffsohn, James S. (ORCID Profile 0000-0003-4673-8927)

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