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| Name | Class |
|---|---|
| The Second People's Hospital of Foshan | OTHER |
| Tianjin Medical University Eye Center | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ortho-k | Active Comparator | Participants will continue to use ortho-k lenses alone. |
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| RLRL+Ortho-k | Experimental | Participants will be treated with RLRL twice a day in addition to ortho-k lenses. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ortho-k lenses | Device | Ortho-k lenses will be administered nightly. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Incidence of treatment-emergent adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiao Yang, Professor | Contact | +86-020-87330348 | 1394392659@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiao Yang, Professor | Zhongshan Ophthalmic Center, Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second People's Hospital of Foshan | Recruiting | Foshan | Guangdong | 528000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38763303 | Derived | 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. |
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| ID | Term |
|---|---|
| D047728 | Myopia, Degenerative |
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
| ID | Term |
|---|---|
| D009216 | Myopia |
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| RLRL | Device | 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. |
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Incidence of treatment-emergent adverse events is the rate of treatment-emergent adverse events over the study period for subjects in both arms. |
| 12 months |
| Zhongshan Ophthalmic Center, Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510060 | China |
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| Tianjin Medical University Eye Center | Recruiting | Tianjin | Tianjin Municipality | 300384 | China |
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