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Effect of Defocus in Soft Contact Lenses on Internal Retinal Vascularization

NCT06527274 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-03-27

No results posted yet for this study

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.

Conditions

  • Nearsightedness

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

Sponsors & Collaborators

  • Bausch & Lomb Incorporated

    collaborator INDUSTRY

  • Université de Montréal

    lead OTHER

Principal Investigators

  • Langis Michaud, OD MS · Universite de Montreal

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-25
Primary Completion
2025-01-31
Completion
2025-03-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06527274 on ClinicalTrials.gov