Fundus Effects of Repeated Low-Level Red-Light Therapy in Chinese Myopic Minors: A Randomized Controlled Clinical Trial
NCT06034912 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70
Last updated 2023-12-05
Summary
1. Research Objective: The primary objective is to investigate the short-term effects of repetitive low-intensity red light therapy on the fundus of the eyes of underage individuals with myopia.
2. Research Design: This experiment employs a prospective, single-center, randomized, controlled clinical research design.
3. Primary Outcome: Changes in macular sensitivity (microperimetry).
4. Recruitment and Participant Information: The study population consists of individuals aged 7 to 17 years old. It is anticipated that there will be 35 participants in both the control group and the experimental group.
5. Trial Location: Zhongshan Ophthalmic Center, Sun Yat-sen University. Contact Information: Shuyu Chen, +190805155537, [email protected].
Conditions
- Red Laser Light-Induced Retinopathy of Both Eyes (Diagnosis)
Interventions
- DEVICE
-
Low-Intensity Red Light Therapy
myopia and amblyopia comprehensive treatment instrument red light feeding treatment
Sponsors & Collaborators
-
Zhongshan Ophthalmic Center, Sun Yat-sen University
lead OTHER
Principal Investigators
-
Ma Jin, professor · Professor at Sun Yat-sen University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 7 Years
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-06-28
- Primary Completion
- 2024-03-29
- Completion
- 2024-05-31
Countries
- China
Study Locations
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