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Customized Contact Lenses

Primary Purpose

Keratoconus

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Customized contact lens
Sponsored by
University of Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Keratoconus

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Able to read and understand the informed consent document in English
  • 18 to 75 years of age
  • Received diagnosis of keratoconus by a clinician
  • Willing and able to follow instructions

Exclusion Criteria:

  • Has best corrected visual acuity of 20/20 or better in the keratoconic eye(s).
  • Normal/typical subjects
  • Is unable to handle, insert, remove or care for the study lenses.
  • Has any active anterior segment disease, pathology, or surgery affecting vision, refraction, or the ability to wear a contact lens
  • History of ocular pharmacological treatment
  • History of ocular trauma or surgery causing abnormal corneal curvature or distorted vision History of contact lens intolerance
  • Pregnant at the time of enrollment in the study (self-reported- It has been shown hormonal changes during pregnancy may affect corneal biomechanics negatively)
  • Adults unable to consent
  • Individuals who are not yet adults (infants, children, teenagers under the age of 18 because it has been shown the average age of the appearance of Keratoconus is the second decade of life ( 15-18 years of age)
  • Prisoners

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Study: Keratoconus

    Arm Description

    Customized contact lenses will be fitted to each study subject based on their own optical defects.

    Outcomes

    Primary Outcome Measures

    Visual acuity
    Snellen "Tumbling E" method will be used to determine the smallest visible letter that a subject can see.
    Contrast sensitivity
    Light and dark sinusoidal stripes (Gabor gratings) will used to determine the smallest contrast that a subject can see.

    Secondary Outcome Measures

    Full Information

    First Posted
    November 11, 2021
    Last Updated
    November 23, 2021
    Sponsor
    University of Houston
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05134909
    Brief Title
    Customized Contact Lenses
    Official Title
    Custom Vision-Corrective Lens Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2021 (Anticipated)
    Primary Completion Date
    March 2024 (Anticipated)
    Study Completion Date
    December 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Houston

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The overall goal of this project is to improve the visual quality of individuals who have abnormal corneal conditions that alter the shape of their cornea (eg. keratoconus). Patients with an abnormal corneal shape have substantial lower and higher order aberrations (distortions in the eye). This results in reduced visual acuity which cannot be corrected by regular sphero-cylindrical correction. Compensating for these aberrations has been challenging due to difficulty measuring their wavefront aberrations accurately and, consequently, manufacturing the custom contact lenses with irregular optical profiles. This project is designed to systematically overcome these obstacles with a customized scleral and/or soft contact lens capable of compensating for the lower and higher order aberrations of the eye.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Keratoconus

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Study: Keratoconus
    Arm Type
    Experimental
    Arm Description
    Customized contact lenses will be fitted to each study subject based on their own optical defects.
    Intervention Type
    Device
    Intervention Name(s)
    Customized contact lens
    Intervention Description
    The customized lenses are designed to correct the eye's optical aberrations.
    Primary Outcome Measure Information:
    Title
    Visual acuity
    Description
    Snellen "Tumbling E" method will be used to determine the smallest visible letter that a subject can see.
    Time Frame
    up to 2 months
    Title
    Contrast sensitivity
    Description
    Light and dark sinusoidal stripes (Gabor gratings) will used to determine the smallest contrast that a subject can see.
    Time Frame
    up to 2 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Able to read and understand the informed consent document in English 18 to 75 years of age Received diagnosis of keratoconus by a clinician Willing and able to follow instructions Exclusion Criteria: Has best corrected visual acuity of 20/20 or better in the keratoconic eye(s). Normal/typical subjects Is unable to handle, insert, remove or care for the study lenses. Has any active anterior segment disease, pathology, or surgery affecting vision, refraction, or the ability to wear a contact lens History of ocular pharmacological treatment History of ocular trauma or surgery causing abnormal corneal curvature or distorted vision History of contact lens intolerance Pregnant at the time of enrollment in the study (self-reported- It has been shown hormonal changes during pregnancy may affect corneal biomechanics negatively) Adults unable to consent Individuals who are not yet adults (infants, children, teenagers under the age of 18 because it has been shown the average age of the appearance of Keratoconus is the second decade of life ( 15-18 years of age) Prisoners
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Geunyoung Yoon, PhD
    Phone
    7137437860
    Email
    gyoon2@central.uh.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ayeswarya Ravikumar, PhD
    Phone
    7137431637
    Email
    aravikum@central.UH.EDU
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Geunyoung Yoon, PhD
    Organizational Affiliation
    University of Houston
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Customized Contact Lenses

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