Repeated Low-Level Red-Light Therapy and Orthokeratology in Fast-progressing Myopia Control
NCT ID: NCT04722874
Last Updated: 2021-08-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
42 participants
INTERVENTIONAL
2021-03-14
2022-06-30
Brief Summary
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Detailed Description
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Orthokeratology (ortho-k) is the first-line optical method in myopia control, resulting in slowing axial elongation by 43-63%. However, results after ortho-k treatment vary among individuals. Methods with more accurate efficacy and wider application to slowing down myopia progression, especially for myopia with limited ortho-k response, are still urgently required.
Repeated low-level red-light (RLRL) therapy is an innovative and non-invasive therapeutic treatment for a variety of eye diseases. Our previous clinical study suggested RLRL could effectively retard myopia progression without clinically observable side effects.
The purpose of this study is to evaluate the adjunctive effect of RLRL and ortho-k on myopia control in ortho-k non-responders using a multicenter randomized controlled trial design. Ortho-k non-responders are defined as who have continuously undergone ortho-k treatment but were still experiencing fast myopia progression. The subjects will be randomly assigned to either experimental group (RLRL and ortho-k) or control group (ortho-k). Their axial length will be monitored over one year. Changes in axial length in the two groups will be compared.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Ortho-k
Participants will continue to use ortho-k lenses alone.
Ortho-k lenses
Ortho-k lenses will be administered nightly.
RLRL+Ortho-k
Participants will be treated with RLRL twice a day in addition to ortho-k lenses.
Ortho-k lenses
Ortho-k lenses will be administered nightly.
RLRL
RLRL will be performed twice a day with an interval of at least 4 hours, each treatment last 3 minutes. Nightly treatment should be performed at least 30 minutes before ortho-k lens insertion.
Interventions
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Ortho-k lenses
Ortho-k lenses will be administered nightly.
RLRL
RLRL will be performed twice a day with an interval of at least 4 hours, each treatment last 3 minutes. Nightly treatment should be performed at least 30 minutes before ortho-k lens insertion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age at enrolment: 8-13 years.
3. Ortho-k non-responders: those who have continuously undergone ortho-k treatment but were still experiencing fast myopia progression (annual axial elongation equal to or more than 0.5 mm) in the past one year in at least one eye.
4. Before wearing ortho-k lenses, spherical equivalent refractions (SERs) ranging from -1.00 to -5.00 Dioptres (D) and astigmatism less than -1.5 D in both eyes, anisometropia less than 1.5 D, and best corrected logMAR visual acuity (VA) equal to or better than 0 in both eyes.
5. Parents' understanding and acceptance of random allocation of grouping
Exclusion Criteria
2. Ocular or systemic abnormalities.
3. Prior treatment of myopia control in the past three months, e.g. drugs, progressive addition lenses, bifocal lenses, etc.
4. Other contraindications.
8 Years
13 Years
ALL
Yes
Sponsors
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The Second People's Hospital of Foshan
OTHER
Tianjin Medical University Eye Center
UNKNOWN
Zhongshan Ophthalmic Center, Sun Yat-sen University
OTHER
Responsible Party
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Principal Investigators
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Xiao Yang, Professor
Role: PRINCIPAL_INVESTIGATOR
Zhongshan Ophthalmic Center, Sun Yat-sen University
Locations
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The Second People's Hospital of Foshan
Foshan, Guangdong, China
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, China
Tianjin Medical University Eye Center
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Xiangbin Kong, PhD
Role: primary
Fabiao Li, MBSS
Role: backup
Ruihua Wei, PhD
Role: primary
References
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Xiong R, Wang W, Tang X, He M, Hu Y, Zhang J, Du B, Jiang Y, Zhu Z, Chen Y, Zhang S, Kong X, Wei R, Yang X, He M. Myopia Control Effect of Repeated Low-Level Red-Light Therapy Combined with Orthokeratology: A Multicenter Randomized Controlled Trial. Ophthalmology. 2024 Nov;131(11):1304-1313. doi: 10.1016/j.ophtha.2024.05.015. Epub 2024 May 18.
Other Identifiers
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2020KYPJ156
Identifier Type: -
Identifier Source: org_study_id
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