Combination Effect of Optical Defocus and Low Dose Atropine in Myopia Control

April 17, 2026 updated by: The Hong Kong Polytechnic University

Combination Effect of Optical Defocus and Low Dose Atropine in Myopia Control - a Randomized Clinical Trial

The purpose of the study is to investigate the combination effect of optical defocus and low dose atropine on myopia control in schoolchildren.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a two-arm randomised controlled trial with a 18-month duration. Participants will be healthy Hong Kong Chinese schoolchildren with low to moderate myopia. The aim is to determine the combination effect of optical defocus and low dose atropine on myopia control in schoolchildren. Optical defocus will be delivered by Defocus Incorporated Multiple Segments (DIMS) spectacle lenses.

A total of 112 Hong Kong Chinese children aged 7 to 12 years (56 in each group) will be recruited and randomly allocated into two groups. One group will receive low dose atropine (0.01%) plus DIMS spectacles (ATD Group); another one will receive low dose atropine (0.01%) plus single vision spectacles (AT Group).

They must have no 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.

Their cycloplegic refraction and axial length will be monitored every six months for 18 months. The changes in refractive errors and axial length between groups will be compared.

Study Type

Interventional

Enrollment (Estimated)

112

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age at enrollment: 7 to 12 years
  • Ethnicity: Hong Kong Chinese
  • Myopia: -0.75D (in spherical equivalent) or above in both eyes
  • Astigmatism: -1.50D or less in both eyes
  • Anisometropia: 1.50D or less (in spherical equivalent) between two eyes
  • Best corrected monocular visual acuity (VA): 0.04 logMAR or better
  • Ocular health: No abnormalities in both internal and external ocular health
  • Systemic health: No abnormalities such as cardiac and respiratory diseases
  • Binocular vision: No strabismus, diplopia, suppression and other binocular abnormalities
  • Normal colour vision
  • No previous refractive surgery or use of myopic control interventions, such as atropine, orthokeratology, and specialized spectacle lenses and contact lenses for myopic control
  • Able to wear the prescribed spectacles
  • No known allergy to atropine

Exclusion Criteria:

  • Eye disease or binocular vision problems (e.g., strabismus, amblyopia, oculomotor nerve palsies, corneal disease, etc.)
  • Previous intraocular or corneal surgery
  • Colour vision deficiencies
  • Systemic disease that may affect vision, vision development (e.g. diabetes mellitus, hypertension, Down syndrome, etc.)
  • Systemic disease that are contradictory to atropine (e.g. asthma, cardiac diseases, etc.)
  • Previous gas permeable, soft bifocal, or orthokeratology contact lenses wear or bifocal / progressive addition lens spectacles wear or use of atropine or pirenzepine (longer than one month of usage)
  • Previous or current participation in myopia control studies
  • Allergy to cyclopentolate hydrochloride or atropine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low dose atropine plus DIMS
This group will receive 0.01% atropine (twice per day: 1 drop in the morning and 1 drop at night before bedtime) and Defocus Incorporated Multiple Segments (DIMS) spectacle lenses
Device: Defocus Incorporated Multiple Segments lenses
Defocus Incorporated Multiple Segments lenses that provide optical defocus for myopia control will be given to this group of participants.
Drug: Low dose atropine
0.01% atropine administrated twice per day (1 drop in the morning and 1 drop at night before bedtime) will be given as intervention.
Experimental: Low dose atropine
This group will receive 0.01% atropine (twice per day: 1 drop in the morning and 1 drop at night before bedtime) and single vision spectacle lenses
Drug: Low dose atropine
0.01% atropine administrated twice per day (1 drop in the morning and 1 drop at night before bedtime) will be given as intervention.
Device: single vision spectacle lenses
Single vision spectacle lenses will be given to this group of participants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in cycloplegic refraction
Time Frame: Baseline, 6th month, 12th month and 18th month
Changes in cycloplegic refraction in spherical equivalent (Dioptres) over 18 months from baseline will be measured.
Baseline, 6th month, 12th month and 18th month
Changes in axial length
Time Frame: Baseline, 6th month, 12th month and 18th month
Changes in axial length (mm) over 18 months from baseline will be measured.
Baseline, 6th month, 12th month and 18th month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hong Kong Polytechnic University

Collaborators

The University of Hong Kong

Investigators

  • Principal Investigator: Rachel Ka Man Chun, PhD, The Hong Kong Polytechnic University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 12, 2024

Primary Completion (Estimated)

May 30, 2026

Study Completion (Estimated)

January 31, 2027

Study Registration Dates

First Submitted

March 20, 2024

First Submitted That Met QC Criteria

April 8, 2024

First Posted (Actual)

April 11, 2024

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 17, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10211476
  • P0041308 (Other Identifier: The Hong Kong Polytechnic University)

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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