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

NCT ID: NCT06358755

Last Updated: 2025-06-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-12
• Study Completion Date: 2026-10-31

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.

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.

Conditions

Myopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Defocus Incorporated Multiple Segments lenses

Intervention Type: DEVICE

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

Low dose atropine

Intervention Type: 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

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

Group Type: EXPERIMENTAL

single vision spectacle lenses

Intervention Type: DEVICE

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

Low dose atropine

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

single vision spectacle lenses

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

Intervention Type: DEVICE

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: collaborator

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rachel Ka Man Chun, PhD

Role: PRINCIPAL_INVESTIGATOR

The Hong Kong Polytechnic University

Locations

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

Hong Kong, , Hong Kong

Countries

Hong Kong

References

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.

Reference Type: DERIVED

PMID: 38923965 (View on PubMed)

Other Identifiers

P0041308

Identifier Type: OTHER

Identifier Source: secondary_id

10211476

Identifier Type: -

Identifier Source: org_study_id