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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06358755
• Other study ID #: 10211476
• Secondary ID: P0041308
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 1, 2024
• Est. completion date: October 31, 2026

Study information

• Verified date: March 2024
• Source: The Hong Kong Polytechnic University
• Contact: Rachel Ka Man Chun, PhD
• Phone: +852-27664224
• Email: rachel.chun[@]polyu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 112
• Est. completion date: October 31, 2026
• Est. primary completion date: April 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Myopia

Intervention

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.
• single vision spectacle lenses
Single vision spectacle lenses 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.

Locations

Country	Name	City	State
Hong Kong	Centre for Myopia Research, The Hong Kong Polytechnic University and Department of Ophthalmology, The University of Hong Kong	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University	The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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