Clinical Trial

Effect of Defocus in Soft Contact Lenses on Internal Retinal Vascularization

Active, Not Recruiting
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-07-24.
Status change: Recruiting → Active, Not Recruiting 2025-03-26
Trial Details
NCT Number NCT06527274
Lead Sponsor Université de Montréal
Collaborators: Bausch & Lomb Incorporated
Conditions Nearsightedness
Enrollment 25 participants
Start Date 2024-06-25
Primary Completion 2025-01-31 (estimated)
Study Completion 2025-03-30 (estimated)
Updated on ClinicalTrials.gov 2025-03-27