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Myopia Control With the Multi-segment Lens

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Multiple-Segment spectacle lens
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

8 Years - 13 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Single vision spectacle lens

Multiple-Segment spectacle lens

Arm Description

Single vision lens with power for correcting distance refraction.

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

Outcomes

Primary Outcome Measures

Cycloplegic Refraction Change in SER
Change in cycloplegic SER (in diopter) that was measured using Shin-Nippon NVision-K 5001 autorefractor.

Secondary Outcome Measures

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

Full Information

First Posted
July 29, 2014
Last Updated
June 15, 2020
Sponsor
The Hong Kong Polytechnic University
Collaborators
HOYA Corporation (Tokyo, Japan)
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1. Study Identification

Unique Protocol Identification Number
NCT02206217
Brief Title
Myopia Control With the Multi-segment Lens
Official Title
The Clinical Trial of Myopia Control in Schoolchildren Using the Multi-segment (MS) Lens
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
August 2014 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University
Collaborators
HOYA Corporation (Tokyo, Japan)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
183 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single vision spectacle lens
Arm Type
No Intervention
Arm Description
Single vision lens with power for correcting distance refraction.
Arm Title
Multiple-Segment spectacle lens
Arm Type
Experimental
Arm Description
A multifocal spectacle lens that corrects distance refraction and provides myopic defocus at the same time.
Intervention Type
Device
Intervention Name(s)
Multiple-Segment spectacle lens
Other Intervention Name(s)
MS lens
Intervention Description
A multifocal spectacle lens that corrects distance refraction and provides myopic defocus images simultaneously. The myopic defocus aims at slowing down myopia progression.
Primary Outcome Measure Information:
Title
Cycloplegic Refraction Change in SER
Description
Change in cycloplegic SER (in diopter) that was measured using Shin-Nippon NVision-K 5001 autorefractor.
Time Frame
Baseline and 2 years
Secondary Outcome Measure Information:
Title
Axial Length
Description
Axial length (mm) was measured after cycloplegia using IOL Master
Time Frame
Baseline and 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carly SY Lam, PhD
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chi ho To, PhD
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Myopia Research, The Hong Kong Polytechnic University
City
Hong Kong
Country
China
Facility Name
Centre for Myopia Research, The Hong Kong Polytechnic University
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31142465
Citation
Lam CSY, Tang WC, Tse DY, Lee RPK, Chun RKM, Hasegawa K, Qi H, Hatanaka T, To CH. Defocus Incorporated Multiple Segments (DIMS) spectacle lenses slow myopia progression: a 2-year randomised clinical trial. Br J Ophthalmol. 2020 Mar;104(3):363-368. doi: 10.1136/bjophthalmol-2018-313739. Epub 2019 May 29.
Results Reference
result

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Myopia Control With the Multi-segment Lens

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