NCT06527274

Effect of Defocus in Soft Contact Lenses on Internal Retinal Vascularization

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Université de Montréal · Academic / Other
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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.

Detailed description

Objective: The aim 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 contact lens used in another (ongoing) research project (NCT05191134). The primary objective of the study is to evaluate changes in retinal blood flow by visualizing retinal vascular density in the superficial and deep plexus following one week's wear of a high peripheral add soft contact lens in a population of young myopic adults. The second objective is to assess changes in choroidal thickness at the macular level after one week's wear of the high peripheral add soft contact lens. A third objective is to evaluate, through questionnaire, the visual comfort provided by this lens design. Materials and methods: 25 myopic participants aged between 18 and 35 will be enrolled. Each participant will be randomly fitted with two lenses: a monofocal spherical soft lens (nesofilcon A) for one week and a high-add bifocal soft lens (anti-myopia) for the same duration of time. Participants will be asked to attend three different visits, one week apart. At visit #1, initial measurements of deep and superficial plexus blood vessel density and choroidal thickness will be taken with an angiographic optical coherence tomograph (OCT-A Triton, Topcon USA). These measurements will be repeated with other lenses at visit 2 and 3. The results will be compared. Participants will be asked to evaluate the visual performance of each lens after 1 week of wear through a questionnaire. Hypothesis: It is expected that one week's wear of the peripheral myopic defocus contact lens will cause an increase in blood vessel density and a thickening of the choroid compared with initial measurements. A decrease in blood vessel density and choroidal thinning is expected after one week's wear of the spherical soft lens (hyperopic defocus), compared with baseline. Both lenses will be well tolerated during daily activities.

Conditions

• Nearsightedness

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-06-25
• Primary completion: 2025-01-31
• Completion: 2025-03-30
• First posted: 2024-07-30
• Last updated: 2025-03-27

Locations

1 site across 1 country: Canada