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

Deborah Laughton; Jennifer S. Hill; Marcella McParland; Vanessa Tasso; Jill Woods; Xiaoying Zhu; Graeme Young; Ruth Craven; Chris Hunt; Jay Neitz; Maureen Neitz; Thomas W. Chalberg; Deborah Jones; James S. Wolffsohn

doi:10.1136/bmjophth-2024-001790

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

Deborah Laughton, Jennifer S. Hill, Marcella McParland, Vanessa Tasso, Jill Woods, Xiaoying Zhu, Graeme Young, Ruth Craven, Chris Hunt, Jay Neitz, Maureen Neitz, Thomas W. Chalberg, Deborah Jones, James S. Wolffsohn

Research output: Contribution to journal › Article › peer-review

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.

Original language	English
Article number	e001790
Number of pages	8
Journal	BMJ Open Ophthalmology
Volume	9
Issue number	1
Early online date	9 Oct 2024
DOIs	https://doi.org/10.1136/bmjophth-2024-001790
Publication status	Published - 9 Oct 2024

Bibliographical note

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/

Access to Document

10.1136/bmjophth-2024-001790Licence: CC BY-NC 4.0

D Laughton et al_ Control of myopia using diffusion optics spectacle lenses_4-year results of CYPRESS_a multicentre randomised controlled_efficacy and safety study
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/
Final published version, 1.01 MBLicence: CC BY-NC 4.0

Cite this

Laughton, D., Hill, J. S., McParland, M., Tasso, V., Woods, J., Zhu, X., Young, G., Craven, R., Hunt, C., Neitz, J., Neitz, M., Chalberg, T. W., Jones, D., & Wolffsohn, J. S. (2024). Control of myopia using diffusion optics spectacle lenses: 4-year results of a multicentre randomised controlled, efficacy and safety study (CYPRESS). BMJ Open Ophthalmology, 9(1), Article e001790. https://doi.org/10.1136/bmjophth-2024-001790

@article{59835d936ac04443bfe628c04620602d,

title = "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.",

author = "Deborah Laughton and Hill, {Jennifer S.} and Marcella McParland and Vanessa Tasso and Jill Woods and Xiaoying Zhu and Graeme Young and Ruth Craven and Chris Hunt and Jay Neitz and Maureen Neitz and Chalberg, {Thomas W.} and Deborah Jones and Wolffsohn, {James S.}",

note = "Copyright {\textcopyright} 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/",

year = "2024",

month = oct,

day = "9",

doi = "10.1136/bmjophth-2024-001790",

language = "English",

volume = "9",

journal = "BMJ Open Ophthalmology",

issn = "2397-3269",

publisher = "BMJ Publishing Group",

number = "1",

}

Laughton, D, Hill, JS, McParland, M, Tasso, V, Woods, J, Zhu, X, Young, G, Craven, R, Hunt, C, Neitz, J, Neitz, M, Chalberg, TW, Jones, D & Wolffsohn, JS 2024, 'Control of myopia using diffusion optics spectacle lenses: 4-year results of a multicentre randomised controlled, efficacy and safety study (CYPRESS)', BMJ Open Ophthalmology, vol. 9, no. 1, e001790. https://doi.org/10.1136/bmjophth-2024-001790

TY - JOUR

T1 - Control of myopia using diffusion optics spectacle lenses

T2 - 4-year results of a multicentre randomised controlled, efficacy and safety study (CYPRESS)

AU - Laughton, Deborah

AU - Hill, Jennifer S.

AU - McParland, Marcella

AU - Tasso, Vanessa

AU - Woods, Jill

AU - Zhu, Xiaoying

AU - Young, Graeme

AU - Craven, Ruth

AU - Hunt, Chris

AU - Neitz, Jay

AU - Neitz, Maureen

AU - Chalberg, Thomas W.

AU - Jones, Deborah

AU - Wolffsohn, James S.

N1 - 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/

PY - 2024/10/9

Y1 - 2024/10/9

N2 - 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.

AB - 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.

UR - https://bmjophth.bmj.com/content/9/1/e001790

UR - http://www.scopus.com/inward/record.url?scp=85205942618&partnerID=8YFLogxK

U2 - 10.1136/bmjophth-2024-001790

DO - 10.1136/bmjophth-2024-001790

M3 - Article

C2 - 39384223

SN - 2397-3269

VL - 9

JO - BMJ Open Ophthalmology

JF - BMJ Open Ophthalmology

IS - 1

M1 - e001790

ER -

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

Abstract

Bibliographical note

Access to Document

Other files and links

Fingerprint

Cite this