The Clinical Trial of Myopia Control in Schoolchildren Using the Multi-segment (MS) Lens
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 183
- Locations
- 2
- Primary Endpoint
- Cycloplegic Refraction Change in SER
Study Overview
Brief Summary
The purpose of this study is to determine if the Multiple-Segment (MS) spectacle lens can slow myopia progression in Hong Kong schoolchildren.
MS lens is also called Defocus Incorporated Multiple Segments (DIMS) spectacle lens
Detailed Description
MS lens is a novel lens designed in attempt to slow myopia progression. It is a multifocal spectacle lens which corrects distance refractive error and at the same time produces myopic defocus images on the retina for all distances. The myopic defocus aims at slowing down myopia progression. The purpose of this study is to investigate if the MS lens can slow myopia progression in Hong Kong Chinese schoolchildren. The subjects will be randomly assigned to either treatment group (wear MS lenses) or control group (wear ordinary single vision lenses). Their cycloplegic refraction and axial length will be monitored every six months over 2 years. The changes in refractive errors and axial length in two groups will be compared.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 8 Years to 13 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age at enrolment: 8-13 year
- •Spherical equivalent refractions (SER): -1.00 to -5.00 Dioptres (D)
- •Astigmatism and anisometropia of 1.50 D or less
- •Spectacle corrected monocular logMAR visual acuity: 0 or better
- •Parents' understanding and acceptance of random allocation of grouping
Exclusion Criteria
- •any ocular and systemic abnormalities might affect visual functions or refractive development
- •prior treatment of myopic control, e.g. drugs, orthokeratology, progressive addition lenses, bifocal lenses, drugs (e.g. atropine), etc.
Outcomes
Primary Outcomes
Cycloplegic Refraction Change in SER
Time Frame: Baseline and 2 years
Change in cycloplegic SER (in diopter) that was measured using Shin-Nippon NVision-K 5001 autorefractor.
Secondary Outcomes
- Axial Length(Baseline and 2 years)
Investigators
Carly Lam
Professor
The Hong Kong Polytechnic University