Repeated Low-Level Red-Light Therapy and Orthokeratology in Fast-progressing Myopia Control

The Multicenter Randomized Clinical Trial of Fast-progressing Myopia Control Using Repeated Low-Level Red-Light Therapy and Orthokeratology

Sponsors

Lead Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University

Collaborator: The Second People's Hospital of Foshan
Tianjin Medical University Eye Center

Source Zhongshan Ophthalmic Center, Sun Yat-sen University
Brief Summary

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.

Detailed Description

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.

Overall Status Not yet recruiting
Start Date 2021-03-01
Completion Date 2022-06-01
Primary Completion Date 2022-06-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Axial length change 12 months
Secondary Outcome
Measure Time Frame
Changes in other ocular parameters 12 months
Incidence of treatment-emergent adverse events 12 months
Enrollment 42
Condition
Intervention

Intervention Type: Device

Intervention Name: Ortho-k lenses

Description: Ortho-k lenses will be administered nightly.

Other Name: Orthokeratology lens

Intervention Type: Device

Intervention Name: RLRL

Description: 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.

Arm Group Label: RLRL+Ortho-k

Other Name: Repeated low-level red-light therapy

Eligibility

Criteria:

Inclusion Criteria: 1. Start to receive ortho-k treatment one year ago. 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 both eyes. 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: 1. Strabismus and binocular vision abnormalities. 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.

Gender:

All

Minimum Age:

8 Years

Maximum Age:

13 Years

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Xiao Yang, Professor Principal Investigator Zhongshan Ophthalmic Center, Sun Yat-sen University
Overall Contact

Last Name: Xiao Yang, Professor

Phone: +86-020-87330348

Email: [email protected]

Location
Facility:
The Second People's Hospital of Foshan | Foshan, Guangdong, 528000, China
Zhongshan Ophthalmic Center, Sun Yat-sen University | Guangzhou, Guangdong, 510060, China Xiao Yang, PhD +86-020-87330348 [email protected] Xiao Yang, PhD Principal Investigator Mingguang He, PhD Principal Investigator
Tianjin Medical University Eye Center | Tianjin, Tianjin, 300384, China Ruihua Wei, PhD
Location Countries

China

Verification Date

2021-03-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Ortho-k

Type: Active Comparator

Description: Participants will continue to use ortho-k lenses alone.

Label: RLRL+Ortho-k

Type: Experimental

Description: Participants will be treated with RLRL twice a day in addition to ortho-k lenses.

Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Outcomes Assessor)

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