Fundus Effects of Repeated Low-Level Red-Light Therapy in Chinese Myopic Minors: A Randomized Controlled Clinical Trial
NCT ID: NCT06034912
Last Updated: 2023-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
70 participants
INTERVENTIONAL
2023-06-28
2024-05-31
Brief Summary
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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].
Detailed Description
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2. Participant Recruitment:
(1) Age range: 7 to 17 years old. (2) Spherical equivalent refraction (SER): -1.00D to -5.00D. (3) Astigmatism: ≤ 2.50D. (4) Anisometropia (difference between the two equivalent spherical lenses): ≤ 1.50D.
(5) Best corrected visual acuity (BCVA) in either eye: ≥ 20/20. (6) Willingness to undergo low-intensity red light treatment. (7) Ability to comprehend the trial's purpose, voluntary participation, and signing of an informed consent form by the subject and their legal guardian.
3.Intervention:Control Group: Daily wear of frame glasses for refractive correction, without any additional treatment for myopia control.Experimental Group: Daily wear of frame glasses for refractive correction, along with low-intensity red light therapy as prescribed by the optometrist.
4.Data Collection: All examinations are conducted by experienced doctors，technicians, and optometrists during objective assessments. Data collection forms are incorporated into the medical records. Specialized research coordinators conduct regular follow-up with all subjects via telephone or WeChat.
5.Ethical Review: The trial protocol was developed before the clinical trial commenced and received approval from the ethics committee.
6.Results and Analysis: Data statistical analysis will be performed using SPSS 26.0 statistical software. The Kolmogorov-Smirnov test will be employed for normality distribution testing. Variables following a normal distribution will be expressed as mean ± standard deviation (Mean±SD). Between-group comparisons will be conducted using one-way analysis of variance. Paired t-tests will be used for pre- and post-red light exposure data. Non-normally distributed data will be expressed as median (interquartile range) \[M(Q)\] and analyzed using rank-sum tests. A significance level of P \< 0.05 will indicate statistically significant differences.
7.Safety and Side Effects: None. 8.Discussion and Conclusion: None.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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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.
Low-Intensity Red Light Therapy
myopia and amblyopia comprehensive treatment instrument red light feeding treatment
Control group
Intervention method: Daily wearing myopia frame glasses (optical monofocal lenses) during the study, no other treatment is used to control myopia.
No interventions assigned to this group
Interventions
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Low-Intensity Red Light Therapy
myopia and amblyopia comprehensive treatment instrument red light feeding treatment
Eligibility Criteria
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Inclusion Criteria
2. Spherical equivalent refraction (SER) -1.00 to -5.00D；
3. Astigmatism≤ 2.50D；
4. Anisometropia (difference between the two equivalent spherical lenses) ≤ 1.50D；
5. Best corrected visual acuity (BCVA) in either eye ≥ 20/20；
6. Currently willing to use low-intensity red light treatment；
7. 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 Criteria
2. Correction of abnormal vision in either eye；
3. 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；
4. Systemic diseases, such as hypertension, lupus erythematosus, albinism, diabetes, etc；
5. previous history of convulsions, tics, central nervous system underdevelopment, psoriasis, epilepsy and psychiatric and psychological diseases；
6. used within 3 months or planned to use low-concentration atropine eye drops during the study；
7. 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；
8. Other situations in which the investigator believes that the patient is not suitable to participate in this study.
7 Years
17 Years
ALL
No
Sponsors
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Zhongshan Ophthalmic Center, Sun Yat-sen University
OTHER
Responsible Party
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Jin Ma
Professor at Sun Yat-sen University, Chief Physician at Sun Yat-sen University Hospital, and Doctoral Supervisor at Sun Yat-sen University.
Principal Investigators
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Ma Jin, professor
Role: STUDY_CHAIR
Professor at Sun Yat-sen University
Locations
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Sun Yat-sen University Zhongshan Ophthalmic Center (Zhujiang New Town Campus)
Guangzhou, , China
Countries
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Central Contacts
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Facility Contacts
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Chen Shuyu
Role: primary
Other Identifiers
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RLRL RCT
Identifier Type: -
Identifier Source: org_study_id