An interventional study of Ortho-k lenses and RLRL in Myopia, Progressive, Refractive Errors and Eye Diseases, sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University. Status unknown at 3 sites in China. Open to participants aged 8 Years to 13 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-13.
Sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University · Not applicable, Interventional, and Treatment
The purpose of this multicenter randomized clinical trial is to evaluate the adjunctive effect of repeated low-level red-light therapy (RLRL) and orthokeratology (ortho-k) on myopia control in ortho-k non-responders who have undergone ortho-k treatment but were still experiencing fast myopia progression.
Myopia constitutes a major threat to personal health globally for its increased prevalence. Moreover, its dose-related association with irreversible blindness complications such as myopic macular degeneration have been demonstrated. It is crucial to look for effective ways to control myopia in children to reduce risk of myopic pathologies in later life.
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.
984 studies on the registry are indexed under Myopia; 210 are open to participants now.
This study's planned enrollment of 42 is below the median of 80 across 783 interventional studies indexed under Myopia.
Browse Myopia studies →Zhongshan Ophthalmic Center, Sun Yat-sen University is the lead sponsor of 159 studies on the registry; 77 are open to participants now.
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Exclusion Criteria:
Participants will continue to use ortho-k lenses alone.
Device: Ortho-k lenses
Participants will be treated with RLRL twice a day in addition to ortho-k lenses.
Device: Ortho-k lenses · Device: RLRL
Ortho-k lenses will be administered nightly.
Also known as: Orthokeratology lens
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.
Also known as: Repeated low-level red-light therapy
Axial length change
Axial length change (mm) is characterized as the difference between 12-month follow-up visit and baseline values. The Lenstar is used to measure axial length (mm).
Time frame: 12 months
Changes in other ocular parameters
The Lenstar is used to measure ocular parameters (e.g., cornea thickness, lens thickness). Change of each parameter is characterized as the difference between its 12-month follow-up visit and baseline values.
Time frame: 12 months
Incidence of treatment-emergent adverse events
Incidence of treatment-emergent adverse events is the rate of treatment-emergent adverse events over the study period for subjects in both arms.
Time frame: 12 months
Plan to share: Yes
No publications or documents are linked to this record.
This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Zhongshan Ophthalmic Center, Sun Yat-sen University