Evaluation of Visual Performance With Contact Lenses

October 11, 2018 updated by: Eric R. Ritchey, University of Houston
This study will evaluate the influence of contact lens optical design on visual performance using standard and multifocal soft contact lenses (MFCLs).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

26

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77204
        • University of Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 39 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Subjects between the ages of 18-39 (inclusive) without significant ocular disease.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
All subjects will wear the 3 contact lenses: Single Vision, Multifocal 1 and Multifocal 2.
Device: Single Vision Contact Lens
Spherical Contact Lens worn on non-dispensing basis
Other Names:
  • comfilcon A
Device: Multifocal Contact Lens 1
Multifocal Contact Lens worn on non-dispensing basis
Other Names:
  • comfilcon A
Device: Multifocal Contact Lens 2
Multifocal Contact Lens worn on non-dispensing basis
Other Names:
  • etafilcon A

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Low Contrast Visual Acuity with Glare
Time Frame: Through study completion, an average of 3 hours
Vision with contact lenses measured under low illumination conditions with glare source
Through study completion, an average of 3 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Low Contrast Visual Acuity without Glare
Time Frame: Through study completion, an average of 3 hours
Vision with contact lenses measured under low illumination conditions without glare source
Through study completion, an average of 3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Houston

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 14, 2018

Primary Completion (Actual)

July 26, 2018

Study Completion (Actual)

July 26, 2018

Study Registration Dates

First Submitted

June 14, 2018

First Submitted That Met QC Criteria

October 11, 2018

First Posted (Actual)

October 15, 2018

Study Record Updates

Last Update Posted (Actual)

October 15, 2018

Last Update Submitted That Met QC Criteria

October 11, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00000958

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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