Clinical trial NCT06358755: Combination Effect of Optical Defocus and Low Dose Atropine in Myopia Control
Official title: Combination Effect of Optical Defocus and Low Dose Atropine in Myopia Control - a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Myopia
Keywords: Myopia control
Defocus
Atropine
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: The University of Hong Kong
First posted: 2024-04-11
Enrollment: 112
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes in cycloplegic refraction
timeFrame: Baseline, 6th month, 12th month and 18th month
measure: Changes in axial length
timeFrame: Baseline, 6th month, 12th month and 18th month
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Centre for Myopia Research, The Hong Kong Polytechnic University and Department of Ophthalmology, The University of Hong Kong
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Rachel Ka Man Chun, PhD
role: PRINCIPAL_INVESTIGATOR
References: