Myopia Control Using Bright Light Therapy, Myopic Defocus and Atropine

NCT04923841 | Completed DMC

• 1 other identifier: R5032-18
• Study Type: interventional
• Target: 577
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Myopia

Keywords

Myopia control; Bright light; Myopic defocus; Atropine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Axial length

  Baseline and 2 years

Study Arms (5)

Control

NO INTERVENTION

Subjects in control will receive single vision spectacle lenses and a placebo desk lamp

BLT monotherapy

EXPERIMENTAL

Subjects in BLT monotherapy group will receive a high intensity light box for bright light therapy and single vision spectacle lenses

Other: High intensity light box for bright light therapy and single vision spectacle lenses

BLT and DIMS

EXPERIMENTAL

Subjects in BLT and DIMS group will receive a high intensity light box for bright light therapy and Defocus Incorporated Multiple Segments (DIMS) spectacle lenses

Other: High intensity light box for bright light therapy and Defocus Incorporated Multiple Segments (DIMS) spectacle lenses

BLT and atropine

EXPERIMENTAL

Subjects in BLT and atropine group will receive a high intensity light box for bright light therapy, single vision spectacle lens, and atropine 0.01% eye drop (twice a day)

Other: High intensity light box for bright light therapy and atropine 0.01% eye drop and and single vision spectacle lenses

Atropine monotherapy

EXPERIMENTAL

Subjects in atropine group will receive atropine 0.01% eye drop (twice a day) and single vision spectacle lenses

Other: Atropine 0.01% eye drop and and single vision spectacle lenses

Interventions

High intensity light box for bright light therapy and single vision spectacle lenses OTHER

High intensity light box for bright light therapy and single vision spectacle lenses

BLT monotherapy

High intensity light box for bright light therapy and atropine 0.01% eye drop and and single vision spectacle lenses OTHER

High intensity light box for bright light therapy and atropine 0.01% eye drop and and single vision spectacle lenses

BLT and atropine

Atropine 0.01% eye drop and and single vision spectacle lenses OTHER

Atropine 0.01% eye drop and and single vision spectacle lenses

Atropine monotherapy

High intensity light box for bright light therapy and Defocus Incorporated Multiple Segments (DIMS) spectacle lenses OTHER

High intensity light box for bright light therapy and Defocus Incorporated Multiple Segments (DIMS) spectacle lenses

BLT and DIMS

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: collaborator
• The Hong Kong Polytechnic University: lead

Study Sites (1)

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

Hong Kong, No postcode, Hong Kong

Location

Related Publications (1)

• Hon Y, Chun RKM, Cheung BKK, Lam DMK, Kong ACW, Ho LM, Lam WC, Lam TC, Lam CS, Lian J, Morgan IG, To CH, Leung CKS, Tse DY. Effectiveness of bright light therapy and combination with myopic defocus for controlling myopic eye growth in schoolchildren: study protocol for a randomised controlled trial (phase 1). BMJ Open Ophthalmol. 2025 May 19;10(1):e002044. doi: 10.1136/bmjophth-2024-002044.

  PMID: 40389302 DERIVED

MeSH Terms

Conditions

Myopia

Interventions

Ultraviolet Therapy; Atropine; Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Phototherapy; Therapeutics; Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Officials

• Chi Ho To, PhD

  School of Optometry, The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2021
• First Posted: June 11, 2021
• Study Start: September 9, 2021
• Primary Completion: March 17, 2026
• Study Completion: March 17, 2026
• Last Updated: May 12, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)