Status:
UNKNOWN
Fundus Effects of Repeated Low-Level Red-Light Therapy in Chinese Myopic Minors: A Randomized Controlled Clinical Trial
Lead Sponsor:
Zhongshan Ophthalmic Center, Sun Yat-sen University
Conditions:
Red Laser Light-Induced Retinopathy of Both Eyes (Diagnosis)
Eligibility:
All Genders
7-17 years
Phase:
NA
Brief 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. Re...
Detailed Description
1. Research Design: This study is an interventional research aimed at investigating the short-term effects of repeated low-intensity red light therapy on the fundus of underage individuals with myopia...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- strabismus (apparent strabismus) or amblyopia；
- Correction of abnormal vision in either eye；
- Any eye disease that may be related to myopia or affect refractive development, such as history of photosensitivity, macular disease, moderate to severe dry eye, corneal disease, cataract, vitreoretinal disease, infectious conjunctivitis, uveitis, optic nerve damage, congenital optic nerve development abnormalities or other eye diseases；
- Systemic diseases, such as hypertension, lupus erythematosus, albinism, diabetes, etc；
- previous history of convulsions, tics, central nervous system underdevelopment, psoriasis, epilepsy and psychiatric and psychological diseases；
- used within 3 months or planned to use low-concentration atropine eye drops during the study；
- Those who have previously used orthokeratology lenses, peripheral defocusing glasses, multifocal soft lenses and other optical therapies to control the progression of myopia, and the elution period is less than three months；
- Other situations in which the investigator believes that the patient is not suitable to participate in this study.
Key Trial Info
Start Date :
June 28 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2024
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06034912
Start Date
June 28 2023
End Date
May 31 2024
Last Update
December 5 2023
Active Locations (1)
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1
Sun Yat-sen University Zhongshan Ophthalmic Center (Zhujiang New Town Campus)
Guangzhou, China