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Myopia Control With the Multi-segment Lens

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ClinicalTrials.gov Identifier: NCT02206217
Recruitment Status : Completed
First Posted : August 1, 2014
Results First Posted : July 31, 2019
Last Update Posted : July 2, 2020
Sponsor:
Collaborator:
HOYA Corporation (Tokyo, Japan)
Information provided by (Responsible Party):
Carly Lam, The Hong Kong Polytechnic University

Study Description
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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


Condition or disease Intervention/treatment Phase
Myopia Device: Multiple-Segment spectacle lens Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 183 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Clinical Trial of Myopia Control in Schoolchildren Using the Multi-segment (MS) Lens
Actual Study Start Date : August 2014
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: Single vision spectacle lens
Single vision lens with power for correcting distance refraction.
Experimental: Multiple-Segment spectacle lens
A multifocal spectacle lens that corrects distance refraction and provides myopic defocus at the same time.
 Device: 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.
Other Name: MS lens


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Axial Length [ Time Frame: Baseline and 2 years ]
    Axial length (mm) was measured after cycloplegia using IOL Master


Eligibility Criteria
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Ages Eligible for Study:   8 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02206217


Locations
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China
Centre for Myopia Research, The Hong Kong Polytechnic University
Hong Kong, China
Hong Kong
Centre for Myopia Research, The Hong Kong Polytechnic University
Hong Kong, Hong Kong
Sponsors and Collaborators
The Hong Kong Polytechnic University
HOYA Corporation (Tokyo, Japan)
Investigators
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Principal Investigator: Carly SY Lam, PhD The Hong Kong Polytechnic University
Principal Investigator: Chi ho To, PhD The Hong Kong Polytechnic University
  Study Documents (Full-Text)

Documents provided by Carly Lam, The Hong Kong Polytechnic University:
Study Protocol and Statistical Analysis Plan  [PDF] July 25, 2014

More Information
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Publications of Results:

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Responsible Party: Carly Lam, Professor, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT02206217    
Other Study ID Numbers: H-ZG3B
First Posted: August 1, 2014    Key Record Dates
Results First Posted: July 31, 2019
Last Update Posted: July 2, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Myopia
Refractive Errors
Eye Diseases