Red Light Intervention on Myopic Progression

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05203432
• Other study ID #: 21Y11910000
• Status: Recruiting
• Phase: N/A
• Start date: February 10, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: January 2022
• Source: Shanghai Eye Disease Prevention and Treatment Center
• Contact: Jiannan Huang
• Phone: +8602153555032
• Email: miller23[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Red Light Intervention
Repeated Low-Level Red-Light Therapy

Drug:
• Atropine
0.01% atropine

Locations

Country	Name	City	State
China	Shanghai Eye Disease Prevention and Treatment Center	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Eye Disease Prevention and Treatment Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change of spherical equivalent	Spherical equivalent as measured by cycloplegia autorefraction	at least 1 year
Secondary	Change of choroidal thickness	Choroidal thickness will be measured using SS-OCT	at least 1 year
Secondary	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