Back to resultsEffectiveness of the Defocus Incorporated Spectacle Lenses on Fast Progressing Myope - Auxiliary Group
Primary Purpose
Myopia
Status
Not yet recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
DIMS spectacle lens
Sponsored by
About this trial
This is an interventional treatment trial for Myopia focused on measuring Myopia, Defocus
Eligibility Criteria
Inclusion Criteria: SER: -1.00D or below Documented history of fast progressing myopia, either in SER or AL SER progression: 0.50D/year or more AL elongation: 0.27mm/year or more Best-corrected monocular visual acuity (VA) in both eyes: 0.00 logMAR (equivalent) or better Acceptance of random group allocation and the masked study design Anisometropia of 1.50 D or less Astigmatism of 2.00 D or less Exclusion Criteria: Strabismus and binocular vision abnormalities Ocular and systemic abnormalities Prior experience of myopia control
Sites / Locations
- School of Optometry, The Hong Kong Polytechnic University
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
DIMS lens group
Arm Description
Participants will be prescribed with a pair of DIMS spectacle lenses for 24 months.
Outcomes
Primary Outcome Measures
Cycloplegic refraction change in spherical equivalent refraction (SER)
Cycloplegic SER (in diopter) will be measured using an open field autorefractor.
Change in SER with cycloplegia from the baseline over a first 12-month period and a 12-month period of follow-up will be measured.
Secondary Outcome Measures
Axial length change
Axial length (mm) will be measured after cycloplegia using a non-contact optical biometer.
Change in axial length from the baseline over a first 12-month period and a 12-month period of follow-up will be measured.
Full Information
NCT ID
NCT05888805
First Posted
May 24, 2023
Last Updated
June 22, 2023
Sponsor
The Hong Kong Polytechnic University
Collaborators
HOYA Lens Thailand LTD.
1. Study Identification
Unique Protocol Identification Number
NCT05888805
Brief Title
Effectiveness of the Defocus Incorporated Spectacle Lenses on Fast Progressing Myope - Auxiliary Group
Official Title
Effectiveness of the Defocus Incorporated Spectacle Lenses on Fast Progressing Myope - Auxiliary Group
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
February 28, 2026 (Anticipated)
Study Completion Date
May 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Hong Kong Polytechnic University
Collaborators
HOYA Lens Thailand LTD.
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 purpose of this study is to examine the efficacy and performance of the Defocus Incorporated Multiple Segments (DIMS) Spectacle lenses on controlling myopia progression in fast progressing myopic children.
Detailed Description
DIMS spectacle lens is a multifocal spectacle lens that produces myopic defocus images and corrects distance refractive errors at the same time.
Participants will be prescribed a pair of DIMS spectacle lenses. Their cycloplegic refraction and axial length will be monitored every 6 months over 2 years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
Keywords
Myopia, Defocus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Participants will be prescribed with a pair of DIMS spectacle lenses for 24 months.
Masking
None (Open Label)
Allocation
N/A
Enrollment
59 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DIMS lens group
Arm Type
Other
Arm Description
Participants will be prescribed with a pair of DIMS spectacle lenses for 24 months.
Intervention Type
Other
Intervention Name(s)
DIMS spectacle lens
Other Intervention Name(s)
MiYOSMART
Intervention Description
DIMS spectacle lens is a multifocal spectacle lens that corrects the distance refraction and provides myopic defocus simultaneously.
Primary Outcome Measure Information:
Title
Cycloplegic refraction change in spherical equivalent refraction (SER)
Description
Cycloplegic SER (in diopter) will be measured using an open field autorefractor.
Change in SER with cycloplegia from the baseline over a first 12-month period and a 12-month period of follow-up will be measured.
Time Frame
Baseline, 1st year and 2nd year
Secondary Outcome Measure Information:
Title
Axial length change
Description
Axial length (mm) will be measured after cycloplegia using a non-contact optical biometer.
Change in axial length from the baseline over a first 12-month period and a 12-month period of follow-up will be measured.
Time Frame
Baseline, 1st year and 2nd year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
SER: -1.00D or below
Documented history of fast progressing myopia, either in SER or AL
SER progression: 0.50D/year or more
AL elongation: 0.27mm/year or more
Best-corrected monocular visual acuity (VA) in both eyes: 0.00 logMAR (equivalent) or better
Acceptance of random group allocation and the masked study design
Anisometropia of 1.50 D or less
Astigmatism of 2.00 D or less
Exclusion Criteria:
Strabismus and binocular vision abnormalities
Ocular and systemic abnormalities
Prior experience of myopia control
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dennis Yan Yin Tse, PhD
Phone
852-27666096
Email
dennis.tse@polyu.edu.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Rachel Ka Man Chun, PhD
Phone
852-27664224
Email
rachel.chun@polyu.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis Yan Yin Tse, PhD
Organizational Affiliation
School of Optometry, The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Optometry, The Hong Kong Polytechnic University
City
Hung Hom
Country
Hong Kong
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effectiveness of the Defocus Incorporated Spectacle Lenses on Fast Progressing Myope - Auxiliary Group
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