Overview

This trial is active, not recruiting.

Condition myopia
Treatment multiple-segment spectacle lens
Sponsor The Hong Kong Polytechnic University
Start date August 2014
End date November 2017
Trial size 183 participants
Trial identifier NCT02206217, H-ZG3B

Summary

The purpose of this study is to determine if the Multiple-Segment (MS) lens can slow myopia progression in Hong Kong schoolchildren.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(No Intervention)
Single vision lens with power for correcting distance refraction.
(Experimental)
A multifocal spectacle lens that corrects distance refraction and provides myopic defocus at the same time.
multiple-segment spectacle lens MS lens
A multifocal spectacle lens that corrects distance refraction and provides myopic defocus images simultaneously. The myopic defocus aims at slowing down myopia progression.

Primary Outcomes

Measure
Cycloplegic refraction
time frame: 2 years

Secondary Outcomes

Measure
Axial length
time frame: 2 years

Eligibility Criteria

Male or female participants from 8 years up to 13 years old.

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.

Additional Information

Official title The Clinical Trial of Myopia Control in Schoolchildren Using the Multi-segment (MS) Lens
Principal investigator Carly SY Lam, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by The Hong Kong Polytechnic University.