Myopia, Progressive
Conditions
Brief summary
The purpose of the study is to quantify the effectiveness of Coopervision MiSight contact lenses in slowing the rate of myopia progression in university students.
Detailed description
MiSight contact lenses have been shown to be a safe and effective way of managing myopia progression in children aged 8-12 years. However, myopic progression is not limited to children of this age group and MiSight lenses have also been shown to be effective in older children aged 11-16 years. There is evidence that progression also occurs in university students. The researchers are therefore investigating the effectiveness of this intervention in a group of UK-based University students.
Interventions
DEVICEMiSight contact lenses
Contact lens for myopia management.
DEVICEProclear contact lenses
Single vision contact lens as control
Sponsors
University of Bradford
University of Huddersfield
CooperVision International Limited (CVIL)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 21 Years
Healthy volunteers
Yes
Inclusion criteria
* Be a myopic students studying at university * Be aged 18-21 years at the start of the study * Show evidence of recent myopia progression prior to commencement of Stage 2 of the study. * Have read the patient information sheet and be happy to sign the consent forms * Be willing to adhere to the visit schedule and wearing times described in this protocol * Agree to lens wearing times of at least 10 hours per day, 6 days per week * Agree to accept either the control or test lens as assigned by the randomisation * Have BCVA of +0.10 logMAR or better in each eye
Exclusion criteria
* Previous myopia control use (optical or pharmacological) * Amblyopia * Ocular pathology such as keratoconus or recurrent corneal infections * Myopic Rx \> 10D * Astigmatism \>1D * Anisometropia \>1.75D * Binocular Vision anomalies (such as Tropia) * Medications that affect pupil size or accommodation * A known allergy to fluorescein or tropicamide * Biomicroscopic findings that would contraindicate contact lens wear * The investigator considers that it is not in the best interest of the subject to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in axial length relative to baseline | Baseline, 24 months |
| Change in spherical equivalent cycloplegic autorefraction relative to baseline | Baseline, 24 months |
Countries
United Kingdom
Contacts
PRINCIPAL_INVESTIGATORKathryn Webber, MOptom
University of Bradford
PRINCIPAL_INVESTIGATORMatthew Cufflin, PhD
University of Hudderfield
PRINCIPAL_INVESTIGATORNiall Hynes, PhD
University of Huddersfield
PRINCIPAL_INVESTIGATORNeema Ghorbani-Mojarrad, PhD
University of Bradford
Outcome results
None listed