Management of Myopia in University Students Using Dual Focus Soft Contact Lenses

Study Overview
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Brief Summary
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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
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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.

Official Title
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Management of Myopia in University Students Using Dual Focus Soft Contact Lenses

Conditions
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Myopia, Progressive

Intervention / Treatment
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* Device: MiSight contact lenses
* Device: Proclear contact lenses


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MiSight dual focus contact lens<br> | Device: MiSight contact lenses<br>* Contact lens for myopia management.<br>|
| Active Comparator: Proclear single vision contact lens<br> | Device: Proclear contact lenses<br>* Single vision contact lens as control<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in axial length relative to baseline |  | Baseline, 24 months | 
| Change in spherical equivalent cycloplegic autorefraction relative to baseline |  | Baseline, 24 months |