Evaluation of Visual Performance With Contact Lenses

Myopia Clinical Trial

Official title:

Evaluation of Visual Performance With Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03705130
• Other study ID #: STUDY00000958
• Status: Completed
• Start date: June 14, 2018
• Est. completion date: July 26, 2018

Study information

• Verified date: October 2018
• Source: University of Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: July 26, 2018
• Est. primary completion date: July 26, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Single Vision Contact Lens
Spherical Contact Lens worn on non-dispensing basis
• Multifocal Contact Lens 1
Multifocal Contact Lens worn on non-dispensing basis
• Multifocal Contact Lens 2
Multifocal Contact Lens worn on non-dispensing basis

Locations

Country	Name	City	State
United States	University of Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Low Contrast Visual Acuity with Glare	Vision with contact lenses measured under low illumination conditions with glare source	Through study completion, an average of 3 hours
Secondary	Low Contrast Visual Acuity without Glare	Vision with contact lenses measured under low illumination conditions without glare source	Through study completion, an average of 3 hours