Fundus Effects of Repeated Low-Level Red-Light Therapy in Chinese Myopic Minors: A Randomized Controlled Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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, chenshuyu980916@163.com.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 7
Maximum Age: 17
Healthy Volunteers: f
View:

• 7\

⁃ 17 years old;

• Spherical equivalent refraction (SER) -1.00 to -5.00D;

• Astigmatism≤ 2.50D;

• Anisometropia (difference between the two equivalent spherical lenses) ≤ 1.50D;

• Best corrected visual acuity (BCVA) in either eye ≥ 20/20;

• Currently willing to use low-intensity red light treatment;

• Be able to understand the purpose of the trial, voluntarily participate and have the subject and his legal guardian sign an informed consent form.

Locations
Other Locations
China
Sun Yat-sen University Zhongshan Ophthalmic Center (Zhujiang New Town Campus)
RECRUITING
Guangzhou
Contact Information
Primary
Chen Shuyu
chenshuyu980916@163.com
+190805155537
Time Frame
Start Date: 2023-06-28
Estimated Completion Date: 2024-05-31
Participants
Target number of participants: 70
Treatments
Experimental: Low-Intensity Red Light Therapy
Intervention method:Daily wearing myopia frame glasses (optical monofocal lenses) and Low-Intensity Red Light therapy during the study to control myopia.
No_intervention: Control group
Intervention method: Daily wearing myopia frame glasses (optical monofocal lenses) during the study, no other treatment is used to control myopia.
Related Therapeutic Areas
Sponsors
Leads: Zhongshan Ophthalmic Center, Sun Yat-sen University

This content was sourced from clinicaltrials.gov