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OpenTrials
Completed

NCT Number: NCT02206217

Myopia Control With the Multi-segment Lens

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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Key information

Age range

8 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Myopia Research, The Hong Kong Polytechnic University, Hong Kong, China

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Multiple-Segment spectacle lens

Device

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

Other names: MS lens

Primary outcomes

  1. 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

  1. Axial Length

    Time frame: Baseline and 2 years

    Axial length (mm) was measured after cycloplegia using IOL Master

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Collaborators

  • Hoya Vision Care

Registry information

Official study title

The Clinical Trial of Myopia Control in Schoolchildren Using the Multi-segment (MS) Lens

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Aug 1, 2014
Registry last updated
Jul 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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