Myopia Control With the Multi-segment Lens

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

183 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2017-07-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Single vision spectacle lens

Single vision lens with power for correcting distance refraction.

Group Type NO_INTERVENTION

No interventions assigned to this group

Multiple-Segment spectacle lens

A multifocal spectacle lens that corrects distance refraction and provides myopic defocus at the same time.

Group Type EXPERIMENTAL

Multiple-Segment spectacle lens

Intervention Type DEVICE

A multifocal spectacle lens that corrects distance refraction and provides myopic defocus images simultaneously. The myopic defocus aims at slowing down myopia progression.

Interventions

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Multiple-Segment spectacle lens

A multifocal spectacle lens that corrects distance refraction and provides myopic defocus images simultaneously. The myopic defocus aims at slowing down myopia progression.

Intervention Type DEVICE

Other Intervention Names

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MS lens

Eligibility Criteria

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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.

Minimum Eligible Age

8 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes