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

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, chenshuyu980916@163.com.

Study Overview

• Status: Recruiting
• Conditions: Red Laser Light-Induced Retinopathy of Both Eyes (Diagnosis)
• Intervention / Treatment: Device: Low-Intensity Red Light Therapy

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. Retinal light damage typically occurs in the photoreceptor layer and retinal pigment epithelium. Optical coherence tomography angiography (OCTA), OCT, pattern visual evoked potentials (VEP), microperimetry, and multifocal electroretinography (ERG) will be utilized to assess the functionality of the retina, choroid, and optic nerve, thus identifying potential areas of damage. This will provide a scientific basis for further evaluating the safety of low-intensity red light therapy.
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.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chen Shuyu; Phone Number: +190805155537; Email: chenshuyu980916@163.com

Study Locations

• China
  • Guangzhou, China
    • Recruiting
    • Sun Yat-sen University Zhongshan Ophthalmic Center (Zhujiang New Town Campus)
    • Contact: Chen Shuyu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Study Population

1. Population Characteristics: Ages 7 to 17 years old.
2. Disease Characteristics: Myopia patients.
3. Recruitment Method: The researcher assesses the eligibility of each patient for inclusion in the study, and if the criteria are met, extends an invitation to participate in the research.
4. Number and Sample Size: 35 participants will be enrolled in each group, for a total of 70 participants.

Description

Inclusion Criteria:

1. 7~17 years old；
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:

1. strabismus (apparent strabismus) or amblyopia；
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: Low-Intensity Red Light Therapy; myopia and amblyopia comprehensive treatment instrument red light feeding treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Latency of P1 waves	Multifocal electroretinogram (mfERG) was used to detect the electrophysiological activity of the local retina of the macula, and the latency of P1 wave was recorded.	Immediately、1 day、1 month、3 months、6 months after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amplitude and latency of P100 waves	Pattern visual evoked potentials (P-VEP) were used to detect the functional integrity of the visual pathway, and the amplitude and latency of the P100 wave were recorded.	Immediately、1 day、1 month、3 months、6 months after treatment
Choroidal thickness	Optical coherence tomography (OCT) was used for choroidal thickness measurement.	Immediately、1 day、1 month、3 months、6 months after treatment
Choroidal and retinal blood flow density assessment	Optical coherence tomography angiography (OCTA) was used to scan the choroidal and retinal scans of both eyes to check the blood flow density .	Immediately、1 day、1 month、3 months、6 months after treatment
Changes in visual acuity in the macula (microperimetry)	All participants were treated with a microperimetry for fundus imaging and microperimetry examination without mydriasis.	Immediately、1 day、1 month、3 months、6 months after treatment
Amplitude of P1 waves	Multifocal electroretinogram (mfERG) was used to detect the electrophysiological activity of the local retina of the macula, and the amplitude of P1 wave (expressed by reaction density) was recorded.	Immediately、1 day、1 month、3 months、6 months after treatment

Collaborators and Investigators

• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
• Investigators: Study Chair: Ma Jin, professor, Professor at Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2023
• Primary Completion (Estimated): March 29, 2024
• Study Completion (Estimated): May 31, 2024

Study Registration Dates

• First Submitted: September 6, 2023
• First Submitted That Met QC Criteria: September 12, 2023
• First Posted (Actual): September 13, 2023

Study Record Updates

• Last Update Posted (Estimated): December 5, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases
• Other Study ID Numbers: RLRL RCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No