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

Not Applicable

• Conditions: Myopia, Progressive
• Interventions: Device: MiSight contact lenses; Device: Proclear contact lenses

• Registration Number: NCT05955638
• Lead Sponsor: University of Bradford

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.

Study Timeline

• Study First Submitted: 2023-07-13
• Study First Submitted QC: 2023-07-13
• Study First Posted: 2023-07-21
• Study Start: 2024-01-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-11
• Last Update Posted: 2024-12-16
• Primary Completion: 2028-09-01
• Study Completion: 2028-09-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 84

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MiSight dual focus contact lens	MiSight contact lenses	-
Proclear single vision contact lens	Proclear contact lenses	-

Primary Outcome Measures

Name	Time	Method
Change in axial length relative to baseline	Baseline, 24 months
Change in spherical equivalent cycloplegic autorefraction relative to baseline	Baseline, 24 months

Trial Locations

Locations (2)

University of Bradford; 🇬🇧 Bradford, West Yorkshire, United Kingdom

University of Huddersfield; 🇬🇧 Huddersfield, United Kingdom