Clinical trial NCT05955638: Management of Myopia in University Students Using Dual Focus Soft Contact Lenses
Official title: Management of Myopia in University Students Using Dual Focus Soft Contact Lenses
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Myopia, Progressive
Lead sponsor: University of Bradford
Sponsor class: OTHER
Collaborators: name: University of Huddersfield
name: CooperVision International Limited (CVIL)
First posted: 2023-07-21
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 21
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in axial length relative to baseline
timeFrame: Baseline, 24 months
measure: Change in spherical equivalent cycloplegic autorefraction relative to baseline
timeFrame: Baseline, 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bradford
country: United Kingdom
facility: University of Bradford
state: West Yorkshire
city: Huddersfield
country: United Kingdom
facility: University of Huddersfield
Study officials:
affiliation: University of Bradford
name: Kathryn Webber, MOptom
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Bradford
name: Matthew Cufflin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Bradford
name: Edward Mallen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Huddersfield
name: Niall Hynes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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