Red Light Intervention on Myopic Progression

• Sponsor: Shanghai Eye Disease Prevention and Treatment Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05203432
• Collaborator: (none)
• Enrollment: 104
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 29.3
• Patients Per Site Per Month: 3.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: Red Light Intervention; Drug: Atropine	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 104 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Effect and Safety of Red Light Intervention on Myopic Progression of Myopic Children: Randomized Clinical Trial
• Anticipated Study Start Date: Jan 20, 2022
• Anticipated Primary Completion Date: Jun 30, 2024
• Anticipated Study Completion Date: Jun 30, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Changes of axial length [at least 1 year]

   AL was measured as the distance from the anterior corneal surface to the retinal pigment epithelium (RPE) using IOLMaster

Secondary Outcome Measures

1. Change of spherical equivalent [at least 1 year]

   Spherical equivalent as measured by cycloplegia autorefraction

2. Change of choroidal thickness [at least 1 year]

   Choroidal thickness will be measured using SS-OCT

3. Change of uncorrected visual acuity [at least 1 year]

   Uncorrected visual acuity (UCVA) will be measured using a mounted and illuminated E chart of the Early Treatment Diabetic Retinopathy study (ETDRS) charts.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 12 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai Eye Disease Prevention and Treatment Center	Shanghai		China	201103

Sponsors and Collaborators

• Shanghai Eye Disease Prevention and Treatment Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shanghai Eye Disease Prevention and Treatment Center
• ClinicalTrials.gov Identifier: NCT05203432
• Other Study ID Numbers: 21Y11910000
• First Posted: Jan 24, 2022
• Last Update Posted: Jan 24, 2022
• Last Verified: Jan 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Myopia; Atropine

Study Results

No Results Posted as of Jan 24, 2022