Myopia Control Using Bright Light Therapy, Myopic Defocus and Atropine

Last updated: June 18, 2024
Sponsor: The Hong Kong Polytechnic University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Myopia

Treatment

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 single vision spectacle lenses

Atropine 0.01% eye drop and and single vision spectacle lenses

Clinical Study ID

NCT04923841
R5032-18
  • Ages 7-12
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 therapydaily.

Exclusion

Exclusion Criteria:

  • Eye disease or binocular vision problems (e.g., strabismus, amblyopia, oculomotornerve palsies, corneal disease, etc.)

  • Previous intraocular or corneal surgery

  • Systemic disease that may affect vision, vision development (e.g. endocrine, cardiacand respiratory diseases, diabetes, Down syndrome, etc.)

  • Allergy to atropine

  • Previous gas permeable, soft bifocal, or orthokeratology contact lens wear orbifocal/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

Study Design

Total Participants: 579
Treatment Group(s): 4
Primary Treatment: High intensity light box for bright light therapy and Defocus Incorporated Multiple Segments (DIMS) spectacle lenses
Phase:
Study Start date:
September 09, 2021
Estimated Completion Date:
March 30, 2026

Study 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.

Connect with a study center

  • Centre for Myopia Research, The Hong Kong Polytechnic University and Department of Ophthalmology, The University of Hong Kong

    Hong Kong, No postcode
    Hong Kong

    Active - Recruiting

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