Myopia
Conditions
Keywords
Myopia control, Defocus, Atropine
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.
Interventions
DEVICEDefocus 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 will be given to this group of participants.
DRUGLow 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.
Sponsors
The Hong Kong Polytechnic University
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
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.
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).
Eligibility
Sex/Gender
ALL
Age
7 Years to 12 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in cycloplegic refraction | Baseline, 6th month, 12th month and 18th month | Changes in cycloplegic refraction in spherical equivalent (Dioptres) over 18 months from baseline will be measured. |
| Changes in axial length | Baseline, 6th month, 12th month and 18th month | Changes in axial length (mm) over 18 months from baseline will be measured. |
Countries
Hong Kong
Contacts
PRINCIPAL_INVESTIGATORRachel Ka Man Chun, PhD
The Hong Kong Polytechnic University
Outcome results
None listed