Myopia Control With the Multi-segment Lens

June 15, 2020 updated by: Carly Lam, The Hong Kong Polytechnic University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

183

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • MS lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Axial Length
Time Frame: Baseline and 2 years
Axial length (mm) was measured after cycloplegia using IOL Master
Baseline and 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hong Kong Polytechnic University

Collaborators

HOYA Corporation (Tokyo, Japan)

Investigators

  • Principal Investigator: Carly SY Lam, PhD, The Hong Kong Polytechnic University
  • Principal Investigator: Chi ho To, PhD, The Hong Kong Polytechnic University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2014

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

July 29, 2014

First Submitted That Met QC Criteria

July 31, 2014

First Posted (Estimate)

August 1, 2014

Study Record Updates

Last Update Posted (Actual)

July 2, 2020

Last Update Submitted That Met QC Criteria

June 15, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-ZG3B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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