Myopia Control Using Bright Light Therapy, Myopic Defocus and Atropine

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Myopia
• Intervention / Treatment: Other: High intensity light box for bright light therapy and single vision spectacle lenses; Other: 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 atropine 0.01% eye drop and and single vision spectacle lenses; Other: Atropine 0.01% eye drop and and single vision spectacle lenses

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 579
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong, No postcode
    • Centre for Myopia Research, The Hong Kong Polytechnic University and Department of Ophthalmology, The University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Subjects in control will receive single vision spectacle lenses and a placebo desk lamp
Experimental: BLT monotherapy; 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; High intensity light box for bright light therapy and single vision spectacle lenses
Experimental: BLT and DIMS; 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; High intensity light box for bright light therapy and Defocus Incorporated Multiple Segments (DIMS) spectacle lenses
Experimental: BLT and atropine; 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; High intensity light box for bright light therapy and atropine 0.01% eye drop and and single vision spectacle lenses
Experimental: Atropine monotherapy; 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; Atropine 0.01% eye drop and and single vision spectacle lenses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Axial length	Axial length (mm) will be measured after cycloplegia using a non-contact optical biometer	Baseline and 2 years

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Collaborators: The University of Hong Kong
• Investigators: Principal Investigator: Chi Ho To, PhD, School of Optometry, The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2021
• Primary Completion (Estimated): August 30, 2025
• Study Completion (Estimated): March 30, 2026

Study Registration Dates

• First Submitted: June 7, 2021
• First Submitted That Met QC Criteria: June 7, 2021
• First Posted (Actual): June 11, 2021

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Myopia control; Atropine; Bright light; Myopic defocus
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Adjuvants, Anesthesia; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Pharmaceutical Solutions; Mydriatics; Ophthalmic Solutions; Atropine
• Other Study ID Numbers: R5032-18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No