Customized Contact Lenses

Sponsor
University of Houston (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05134909
Collaborator
(none)
60
1
37

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Customized contact lens
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Custom Vision-Corrective Lens Study
Anticipated Study Start Date :
Nov 1, 2021
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Study: Keratoconus

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

Device: Customized contact lens
The customized lenses are designed to correct the eye's optical aberrations.

Outcome Measures

Primary Outcome Measures

  1. Visual acuity [up to 2 months]

    Snellen "Tumbling E" method will be used to determine the smallest visible letter that a subject can see.

  2. Contrast sensitivity [up to 2 months]

    Light and dark sinusoidal stripes (Gabor gratings) will used to determine the smallest contrast that a subject can see.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Houston

Investigators

  • Principal Investigator: Geunyoung Yoon, PhD, University of Houston

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Geunyoung Yoon, Professor, University of Houston
ClinicalTrials.gov Identifier:
NCT05134909
Other Study ID Numbers:
  • STUDY00003195
First Posted:
Nov 26, 2021
Last Update Posted:
Nov 26, 2021
Last Verified:
Nov 1, 2021
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:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 26, 2021