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Evaluation of Visual Performance With Contact Lenses

Sponsor
University of Houston (Other)
Overall Status
Completed
CT.gov ID
NCT03705130
Collaborator
(none)
26
Enrollment
1
Location
1.4
Actual Duration (Months)
18.8
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • 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

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 :
Jun 14, 2018
Actual Primary Completion Date :
Jul 26, 2018
Actual Study Completion Date :
Jul 26, 2018

Arms and Interventions

Arm 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 39 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 University of Houston Houston Texas United States 77204

    Sponsors and Collaborators

    • University of Houston

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eric R. Ritchey, Assistant Professor, University of Houston
    ClinicalTrials.gov Identifier:
    NCT03705130
    Other Study ID Numbers:
    • STUDY00000958
    First Posted:
    Oct 15, 2018
    Last Update Posted:
    Oct 15, 2018
    Last Verified:
    Oct 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Eric R. Ritchey, Assistant Professor, University of Houston
    Multifocal Contact Lens
    Myopia
    Visual Performance
    Additional relevant MeSH terms:
    Myopia

    Study Results

    No Results Posted as of Oct 15, 2018