Status:
UNKNOWN
Repeated Low-Level Red-Light Therapy and Orthokeratology in Fast-progressing Myopia Control
Lead Sponsor:
Zhongshan Ophthalmic Center, Sun Yat-sen University
Collaborating Sponsors:
The Second People's Hospital of Foshan
Tianjin Medical University Eye Center
Conditions:
Myopia, Progressive
Refractive Errors
Eligibility:
All Genders
8-13 years
Phase:
NA
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...
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 dege...
Eligibility Criteria
Inclusion
- Start to receive ortho-k treatment one year ago.
- Age at enrolment: 8-13 years.
- 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.
- 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.
- Parents' understanding and acceptance of random allocation of grouping
Exclusion
- Strabismus and binocular vision abnormalities.
- Ocular or systemic abnormalities.
- Prior treatment of myopia control in the past three months, e.g. drugs, progressive addition lenses, bifocal lenses, etc.
- Other contraindications.
Key Trial Info
Start Date :
March 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2022
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04722874
Start Date
March 14 2021
End Date
June 1 2022
Last Update
August 13 2021
Active Locations (3)
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1
The Second People's Hospital of Foshan
Foshan, Guangdong, China, 528000
2
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, China, 510060
3
Tianjin Medical University Eye Center
Tianjin, Tianjin Municipality, China, 300384