Myopia Control Using Optimized Optical Defocus RCTs
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Myopia
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Participant, Investigator)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.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 8 years and 13 years
- Gender
- Both males and females
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 ...
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.
Tracking Information
- NCT #
- NCT03681366
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Carly SY Lam, phD School of Optometry, The Hong Kong Polytechnic University
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