Myopia
Conditions
Keywords
myopia, Myopic Defocus, contact lens, myopia control
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.
Interventions
DEVICEDISC3.5 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.
Sponsors
The Hong Kong Polytechnic University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, 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.
Eligibility
Sex/Gender
ALL
Age
8 Years to 13 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cycloplegic Refraction Change in SER | 12 months | Change in cycloplegic autorefraction in spherical equivalent (SER) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Axial length | 12 months | Axial length (mm) was measured after cycloplegia |
Countries
China
Outcome results
None listed