Evaluation of Visual Performance With Contact Lenses

Completed

• Conditions: Myopia
• Interventions: Device: Single Vision Contact Lens; Device: Multifocal Contact Lens 1; Device: Multifocal Contact Lens 2

• Registration Number: NCT03705130
• Lead Sponsor: University of Houston

Brief Summary

This study will evaluate the influence of contact lens optical design on visual performance using standard and multifocal soft contact lenses (MFCLs).

Detailed Description

The study will examine visual acuity with various contact lenses, with and without glare source, in myopes between the ages of 18-39 years old (inclusive) to determine the effect of different multifocal optical designs on visual performance in the post-fit period.

Study Timeline

• Study Start: 2018-06-14
• Study First Submitted: 2018-06-14
• Primary Completion: 2018-07-26
• Study Completion: 2018-07-26
• Status Verified: 2018-10
• Study First Submitted QC: 2018-10-11
• Last Update Submitted: 2018-10-11
• Study First Posted: 2018-10-15
• Last Update Posted: 2018-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• 18 to 39 years of age
• Best corrected visual acuity of at least 20/30
• Spherical equivalent refractive error in each eye of between -0.75 and -6.00 diopters sphere after vertexing to the corneal plane

Exclusion Criteria

• Greater than -1.00 diopter of refractive astigmatism at the corneal plane
• Any active anterior segment disease, pathology, or surgery affecting vision, refraction, or the ability to wear a soft contact lens
• History of ocular trauma or surgery causing abnormal or distorted vision
• Current Rigid Gas Permeable (RGP) contact lens wearers
• Unwilling to have eyes photographed or video recorded
• Pregnant and/or lactating females, by self-report

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Multifocal Contact Lens 2	All subjects will wear the 3 contact lenses: Single Vision, Multifocal 1 and Multifocal 2.
Group 1	Single Vision Contact Lens	All subjects will wear the 3 contact lenses: Single Vision, Multifocal 1 and Multifocal 2.
Group 1	Multifocal Contact Lens 1	All subjects will wear the 3 contact lenses: Single Vision, Multifocal 1 and Multifocal 2.

Primary Outcome Measures

Name	Time	Method
Low Contrast Visual Acuity with Glare	Through study completion, an average of 3 hours	Vision with contact lenses measured under low illumination conditions with glare source

Secondary Outcome Measures

Name	Time	Method
Low Contrast Visual Acuity without Glare	Through study completion, an average of 3 hours	Vision with contact lenses measured under low illumination conditions without glare source

Trial Locations

Locations (1)

University of Houston; 🇺🇸 Houston, Texas, United States