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Evaluation of Visual Performance With Contact Lenses

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ClinicalTrials.gov Identifier: NCT03705130
Recruitment Status : Completed
First Posted : October 15, 2018
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
Eric R. Ritchey, University of Houston

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

Condition or disease Intervention/treatment
Myopia Device: Single Vision Contact Lens Device: Multifocal Contact Lens 1 Device: Multifocal Contact Lens 2

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 Design
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Study Type : Observational
Actual Enrollment : 26 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of Visual Performance With Contact Lenses
Actual Study Start Date : June 14, 2018
Actual Primary Completion Date : July 26, 2018
Actual Study Completion Date : July 26, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Groups and Cohorts
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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 Name: comfilcon A

Device: Multifocal Contact Lens 1
Multifocal Contact Lens worn on non-dispensing basis
Other Name: comfilcon A

Device: Multifocal Contact Lens 2
Multifocal Contact Lens worn on non-dispensing basis
Other Name: etafilcon A


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Subjects between the ages of 18-39 (inclusive) without significant ocular disease.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03705130


Locations
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United States, Texas
University of Houston
Houston, Texas, United States, 77204
Sponsors and Collaborators
University of Houston
More Information
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Responsible Party: Eric R. Ritchey, Assistant Professor, University of Houston
ClinicalTrials.gov Identifier: NCT03705130     History of Changes
Other Study ID Numbers: STUDY00000958
First Posted: October 15, 2018    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Eric R. Ritchey, University of Houston:
Multifocal Contact Lens
Myopia
Visual Performance
Additional relevant MeSH terms:
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Myopia
Refractive Errors
Eye Diseases