Myopia Control With the Multi-segment Lens

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: Multiple-Segment spectacle lens

• Registration Number: NCT02206217
• Lead Sponsor: The Hong Kong Polytechnic University

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 Timeline

• Study First Submitted: 2014-07-29
• Study First Submitted QC: 2014-07-31
• Study Start: 2014-08
• Study First Posted: 2014-08-01
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Results First Submitted: 2018-05-16
• Results First Submitted QC: 2019-06-09
• Results First Posted: 2019-07-31
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-15
• Last Update Posted: 2020-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 183

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multiple-Segment spectacle lens	Multiple-Segment spectacle lens	A multifocal spectacle lens that corrects distance refraction and provides myopic defocus at the same time.

Primary Outcome Measures

Name	Time	Method
Cycloplegic Refraction Change in SER	Baseline and 2 years	Change in cycloplegic SER (in diopter) that was measured using Shin-Nippon NVision-K 5001 autorefractor.

Secondary Outcome Measures

Name	Time	Method
Axial Length	Baseline and 2 years	Axial length (mm) was measured after cycloplegia using IOL Master

Trial Locations

Locations (1)

Centre for Myopia Research, The Hong Kong Polytechnic University; 🇭🇰 Hong Kong, Hong Kong