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

NCT06358755 | Active Not Recruiting DMC

• 2 other identifiers: 10211476P0041308
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Myopia

Keywords

Myopia control; Defocus; Atropine

Outcome Measures

Primary Outcomes (2)

• Changes in cycloplegic refraction

  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

  Changes in axial length (mm) over 18 months from baseline will be measured.

  Baseline, 6th month, 12th month and 18th month

Study Arms (2)

Low dose atropine plus DIMS

EXPERIMENTAL

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; Drug: Low dose atropine

Low dose atropine

EXPERIMENTAL

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

Device: single vision spectacle lenses; Drug: Low dose atropine

Interventions

Defocus Incorporated Multiple Segments lenses DEVICE

Defocus Incorporated Multiple Segments lenses that provide optical defocus for myopia control will be given to this group of participants.

Low dose atropine plus DIMS

single vision spectacle lenses DEVICE

Single vision spectacle lenses will be given to this group of participants.

Low dose atropine

Low dose atropine DRUG

0.01% atropine administrated twice per day (1 drop in the morning and 1 drop at night before bedtime) will be given as intervention.

Low dose atropine; Low dose atropine plus DIMS

Eligibility Criteria

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

You may qualify if:

• 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

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
• 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

Sponsors & Collaborators

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

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)

• Chun RKM, Hon Y, Law TK, Wong KYQ, To CH, Shih KC, Leung CKS, Tse DYY. Combination effect of optical defocus and low dose atropine in myopia control: Study protocol for a randomized clinical trial. PLoS One. 2024 Jun 26;19(6):e0306050. doi: 10.1371/journal.pone.0306050. eCollection 2024.

  PMID: 38923965 DERIVED

MeSH Terms

Conditions

Myopia

Interventions

Atropine

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Rachel Ka Man Chun, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigators, including ophthalmologists and optometrists, who are responsible for collection of data related to myopia progression and analysis of data will be blinded to study intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Eligible participants will be randomly allocated into 2 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).

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: April 11, 2024
• Study Start: July 12, 2024
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)