Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
167 participants
INTERVENTIONAL
2018-10-25
2022-06-24
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
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.
Study Groups
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Single vision soft contact lens
single vision, spherical soft contact lens
No interventions assigned to this group
DISC3.5 Plus lens
A soft contact lens that comprises of simultaneous distance optical prescription and myopic defocus areas.
DISC3.5 plus
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.
Interventions
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DISC3.5 plus
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
8 Years
13 Years
ALL
Yes
Sponsors
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The Hong Kong Polytechnic University
OTHER
Responsible Party
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Carly Lam
Professor
Principal Investigators
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Carly SY Lam, phD
Role: PRINCIPAL_INVESTIGATOR
School of Optometry, The Hong Kong Polytechnic University
Locations
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The Centre of Myopia Ressearch, School of Optometry, The Hong Kong PolyU
Hong Kong, , China
Countries
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Other Identifiers
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HSEARS20180711001
Identifier Type: -
Identifier Source: org_study_id
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