Red Light Intervention on Myopic Progression

The Effect and Safety of Red Light Intervention on Myopic Progression of Myopic Children: Randomized Clinical Trial

To explore the effectiveness of using repeated low-level red-light therapy to slow myopia progression.

Study Overview

• Status: Recruiting
• Conditions: Myopia
• Intervention / Treatment: Device: Red Light Intervention; Drug: Atropine

• Study Type: Interventional
• Enrollment (Anticipated): 104
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jiannan Huang; Phone Number: +8602153555032; Email: miller23@126.com
• Study Contact Backup: Name: Xiangui He; Phone Number: +8602153555032; Email: hxgcrco@shsyf.com

Study Locations

• China
  • Shanghai, China, 201103
    • Recruiting
    • Shanghai Eye Disease Prevention and Treatment Center
    • Contact: Xiangui He; Phone Number: +862153555032; Email: hxgcrco@shsyf.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age at enrolment: 6-12 years;
2. At least one eye with spherical equivalent refractions (SERs): -1.00 to -5.00 diopters (D), and stigmatism of 1.50 D or less;
3. Anisometropia of 1.5 D or less;
4. The BCVA of distant vision is at least 0.8;
5. Myopia progressed more than 0.5D in the past year;
6. Have normal thinking and language communication skills, and be able to actively cooperate with the treatment as required;
7. Written informed consent of guardian and child.

Exclusion Criteria:

1. Strabismus, amblyopia or other ocular abnormalities;
2. Other systemic abnormalities;
3. Prior treatment of myopia control in 6 months, e.g. drugs, orthokeratology, progressive addition lenses, bifocal lenses, etc in either eye;
4. Atropine allergy;
5. Other situations that not suitable for participating in the trial as judged by the researcher.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Red Light Intervention; Repeated Low-Level Red-Light Therapy	Device: Red Light Intervention; Repeated Low-Level Red-Light Therapy
Active Comparator: Low concentration atropine; 0.01% atropine	Drug: Atropine; 0.01% atropine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of axial length	AL was measured as the distance from the anterior corneal surface to the retinal pigment epithelium (RPE) using IOLMaster	at least 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of spherical equivalent	Spherical equivalent as measured by cycloplegia autorefraction	at least 1 year
Change of choroidal thickness	Choroidal thickness will be measured using SS-OCT	at least 1 year
Change of uncorrected visual acuity	Uncorrected visual acuity (UCVA) will be measured using a mounted and illuminated E chart of the Early Treatment Diabetic Retinopathy study (ETDRS) charts.	at least 1 year

Collaborators and Investigators

• Sponsor: Shanghai Eye Disease Prevention and Treatment Center
• Investigators: Principal Investigator: Jiannan Huang, Shanghai Eye Disease Prevention and Treatment Center

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2022
• Primary Completion (Anticipated): June 30, 2024
• Study Completion (Anticipated): June 30, 2024

Study Registration Dates

• First Submitted: January 10, 2022
• First Submitted That Met QC Criteria: January 10, 2022
• First Posted (Actual): January 24, 2022

Study Record Updates

• Last Update Posted (Actual): October 12, 2022
• Last Update Submitted That Met QC Criteria: October 7, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Adjuvants, Anesthesia; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Mydriatics; Atropine
• Other Study ID Numbers: 21Y11910000

Drug and device information, study documents

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