Myopia Control Using Bright Light Therapy, Myopic Defocus and Atropine

Myopia Clinical Trial

Official title:

Effectiveness of Bright Light Therapy, Myopic Defocus, Atropine and the Combinations for Controlling Myopic Eye Growth in Schoolchildren: A Randomized Control Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04923841
• Other study ID #: R5032-18
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 9, 2021
• Est. completion date: March 30, 2026

Study information

• Verified date: April 2024
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to investigate the effect of bright light therapy, myopic defocus, atropine and the combination in myopia control in schoolchildren.

Description:

The present study is a multi-arm randomised clinical trial with a 24-month duration. Subjects will be healthy Hong Kong Chinese schoolchildren with low to moderate myopia. The aims are to determine the clinical effectiveness of bright light therapy on inhibiting myopia progression in schoolchildren, and to determine whether combination therapy using bright light therapy (BLT) and myopic defocus is more effective than monotherapy. Study population Seven hundred and sixty Hong Kong Chinese children (152 in each) of A. Control group, B. BLT only group, C. BLT and Defocus Incorporated Multiple Segments (DIMS) group, D. BLT and atropine 0.01% group) and E. Atropine 0.01% group aged 7-12 years old will be recruited. They must not have had prior or current myopia control treatment, have no ocular or systemic diseases/abnormalities that affect visual function, refractive development or spectacle lens wear, and no previous intraocular or corneal surgery. They must not have allergy to atropine. The eligible subjects will be randomly assigned into one of the four groups. Their cycloplegic refraction and axial length will be monitored every six months for 2 years. The changes in refractive errors and axial length between groups will be compared.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 579
• Est. completion date: March 30, 2026
• Est. primary completion date: August 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

Inclusion Criteria:

• Myopia of at least -0.75D (spherical equivalent) in both eyes
• Age at enrolment: 7-12 year; Hong Kong Chinese
• Astigmatism and anisometropia: 1.50D or less
• Spectacle corrected monocular visual acuity (VA): 0.0 logMAR or better
• Parents' understanding and acceptance of random allocation of grouping and masking
• Able to wear the prescribed spectacle, put on eye drop and undergo light therapy daily.

Exclusion Criteria:

• Eye disease or binocular vision problems (e.g., strabismus, amblyopia, oculomotor nerve palsies, corneal disease, etc.)
• Previous intraocular or corneal surgery
• Systemic disease that may affect vision, vision development (e.g. endocrine, cardiac and respiratory diseases, diabetes, Down syndrome, etc.)
• Allergy to atropine
• Previous gas permeable, soft bifocal, or orthokeratology contact lens wear or bifocal/PAL/specific myopic control spectacle wear or use of atropine or pirenzepine (longer than 1 month of wear)
• Previous or current participation in myopia control studies

Related Conditions & MeSH terms

• Myopia

Intervention

Other:
• High intensity light box for bright light therapy and single vision spectacle lenses
High intensity light box for bright light therapy and single vision spectacle lenses
• High intensity light box for bright light therapy and Defocus Incorporated Multiple Segments (DIMS) spectacle lenses
High intensity light box for bright light therapy and Defocus Incorporated Multiple Segments (DIMS) spectacle lenses
• High intensity light box for bright light therapy and atropine 0.01% eye drop and and single vision spectacle lenses
High intensity light box for bright light therapy and atropine 0.01% eye drop and and single vision spectacle lenses
• Atropine 0.01% eye drop and and single vision spectacle lenses
Atropine 0.01% eye drop and and single vision spectacle lenses

Locations

Country	Name	City	State
Hong Kong	Centre for Myopia Research, The Hong Kong Polytechnic University and Department of Ophthalmology, The University of Hong Kong	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University	The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cycloplegic Refraction Change in spherical equivalent refraction (SER)	Change in cycloplegic SER (in diopter) will be measured using an open field autorefractor	Baseline and 2 years
Secondary	Axial length	Axial length (mm) will be measured after cycloplegia using a non-contact optical biometer	Baseline and 2 years