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ACTIVE NOT RECRUITING
NCT06527274
NA

Effect of Defocus in Soft Contact Lenses on Internal Retinal Vascularization

Sponsor: Université de Montréal

View on ClinicalTrials.gov

Summary

The purpose of this study is to gain a better understanding of the retinal vascular changes that occur in response to the optical effect of a myopic defocus daily disposable soft contact lens (MDSL) in a group of healthy young myopic adults (18-35 years; myopia -1.00D to -4.00D; all genders). It will also learn about the acceptance of this visual correction modality compared to regular contact lenses. The main questions to be answered are: * To evaluate changes in retinal blood flow by visualizing retinal vascular density in the superficial and deep plexus after one week of MDSL wear. * To evaluate changes in choroidal thickness at the macular level after one week of MDSL wear. * To evaluate the visual comfort provided by this MDSL design using a questionnaire. Researchers will compare the MDSL to a daily disposable single vision soft lens (SVSL) used to correct myopia to determine if the addition of a defocus area makes a difference in the retinal response to the visual signal. Participants will be required to * Wear both MDSL and SVSL for one week each, in a random order. * Read letters to measure visual acuity * Have a deep scan of their retina with an optical coherence tomography (OCT) device * Rate the comfort and vision provided by both devices using a questionnaire.

Key Details

Gender

All

Age Range

18 Years - 35 Years

Study Type

INTERVENTIONAL

Enrollment

25

Start Date

2024-06-25

Completion Date

2025-03-30

Last Updated

2025-03-27

Healthy Volunteers

Yes

Conditions

Interventions

DEVICE

Experimental: Myopic defocus soft lens design (MDSL)

An optical device designed to provide a myopic defocus to control myopia progression

DEVICE

Active Comparator: Single vision soft lens design (SVSL

An optical device designed to correct refractive error like myopia

Locations (1)

Universite de Montreal

Montreal, Quebec, Canada