Back to resultsMyopia Control Using Optimized Optical Defocus RCTs
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
DISC3.5 plus
Sponsored by
About this trial
This is an interventional treatment trial for Myopia focused on measuring myopia, Myopic Defocus, contact lens, myopia control
Eligibility Criteria
Inclusion Criteria:
- Age at enrolment: 8-13 year; Hong Kong Chinese
- Spherical equivalent refractions (SER): -1.00 to -5.00D
- Astigmatism: -1.00D or less
- Anisometropia: 1.25D or less
- Spectacle corrected monocular visual acuity (VA): 0.0 logMAR or better
- Contact lens corrected monocular VA: 0.1 logMAR or better
- Normal binocular function
- Willingness to wear contact lenses regularly
- Parents' understanding and acceptance of random allocation of grouping and masking
Exclusion Criteria:
- Prior myopia control treatment, e.g. orthokeratology, defocus soft contact lenses, progressive addition lenses, bifocal lenses, drugs (e.g. atropine), etc.
- Strabismus or decompensated phoria (checked by cover test at far and near in screening)
- Known contraindications for contact lens wear
- Have any ocular and systemic diseases and abnormalities that might affect visual function or refractive development
Sites / Locations
- The Centre of Myopia Ressearch, School of Optometry, The Hong Kong PolyU
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Single vision soft contact lens
DISC3.5 Plus lens
Arm Description
single vision, spherical soft contact lens
A soft contact lens that comprises of simultaneous distance optical prescription and myopic defocus areas.
Outcomes
Primary Outcome Measures
Cycloplegic Refraction Change in SER
Change in cycloplegic autorefraction in spherical equivalent (SER)
Secondary Outcome Measures
Axial length
Axial length (mm) was measured after cycloplegia
Full Information
NCT ID
NCT03681366
First Posted
September 20, 2018
Last Updated
August 22, 2022
Sponsor
The Hong Kong Polytechnic University
1. Study Identification
Unique Protocol Identification Number
NCT03681366
Brief Title
Myopia Control Using Optimized Optical Defocus RCTs
Official Title
Myopia Control Using Optimized Optical Defocus in Schoolchildren - a Randomized Double Masked Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
October 25, 2018 (Actual)
Primary Completion Date
May 8, 2021 (Actual)
Study Completion Date
June 24, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aims of the study is to evaluate whether the DISC3.5 Plus contact lens will slow myopia progression and axial length growth in myopic children as compared with single vision soft contact lenses.
Detailed Description
The purpose of the current study is to evaluate whether the DISC3.5 Plus contact lens will slow myopia progression and axial length growth in myopic children as compared with single vision soft contact lenses.
The Defocus Incorporated Soft 3.5 Plus Contact Lens (DISC3.5 Plus) is a soft contact lens that comprises of simultaneous distance optical prescription and myopic defocus areas.
The efficacy of the DISC3.5 Plus lens in slowing myopia progression (change in refractive error) will be compared to a spherical (front and back surface) single vision soft contact lenses in this one-year prospective, randomised and double-masked clinical trial. The hypothesis of this study is that the DISC3.5 Plus will slow myopia progression more than spherical single vision soft contact lenses.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
Keywords
myopia, Myopic Defocus, contact lens, myopia control
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Double masked design:
The investigator(s) who were responsible for refracting and performing relevant ocular data measurement were masked from the grouping of the subjects.
The unmasked investigator(s) were responsible for group allocation, spectacle-dispensing work, measuring lens visual performance, record keeping, data entry and compliance checking. Data input was carefully checked by the unmasked investigator and the other researchers independently.
The children and their parents were also masked to group allocation until the data analysis was completed.
Allocation
Randomized
Enrollment
167 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single vision soft contact lens
Arm Type
No Intervention
Arm Description
single vision, spherical soft contact lens
Arm Title
DISC3.5 Plus lens
Arm Type
Experimental
Arm Description
A soft contact lens that comprises of simultaneous distance optical prescription and myopic defocus areas.
Intervention Type
Device
Intervention Name(s)
DISC3.5 plus
Intervention Description
The Defocus Incorporated Soft 3.5 Plus Contact Lens (DISC3.5 Plus) is a soft contact lens that comprises of simultaneous distance optical prescription and myopic defocus areas.
Primary Outcome Measure Information:
Title
Cycloplegic Refraction Change in SER
Description
Change in cycloplegic autorefraction in spherical equivalent (SER)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Axial length
Description
Axial length (mm) was measured after cycloplegia
Time Frame
12 months
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; Hong Kong Chinese
Spherical equivalent refractions (SER): -1.00 to -5.00D
Astigmatism: -1.00D or less
Anisometropia: 1.25D or less
Spectacle corrected monocular visual acuity (VA): 0.0 logMAR or better
Contact lens corrected monocular VA: 0.1 logMAR or better
Normal binocular function
Willingness to wear contact lenses regularly
Parents' understanding and acceptance of random allocation of grouping and masking
Exclusion Criteria:
Prior myopia control treatment, e.g. orthokeratology, defocus soft contact lenses, progressive addition lenses, bifocal lenses, drugs (e.g. atropine), etc.
Strabismus or decompensated phoria (checked by cover test at far and near in screening)
Known contraindications for contact lens wear
Have any ocular and systemic diseases and abnormalities that might affect visual function or refractive development
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carly SY Lam, phD
Organizational Affiliation
School of Optometry, The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Centre of Myopia Ressearch, School of Optometry, The Hong Kong PolyU
City
Hong Kong
Country
China
12. IPD Sharing Statement
Learn more about this trial
Myopia Control Using Optimized Optical Defocus RCTs
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