Customized Contact Lenses

NCT05134909 | Unknown

• 1 other identifier: STUDY00003195
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Keratoconus

Outcome Measures

Primary Outcomes (2)

• Visual acuity

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

  up to 2 months

• Contrast sensitivity

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

  up to 2 months

Study Arms (1)

Study: Keratoconus

EXPERIMENTAL

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

Device: Customized contact lens

Interventions

Customized contact lens DEVICE

The customized lenses are designed to correct the eye's optical aberrations.

Study: Keratoconus

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Houston: lead

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Study Officials

• Geunyoung Yoon, PhD

  University of Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Geunyoung Yoon, PhD

CONTACT

7137437860; gyoon2@central.uh.edu

Ayeswarya Ravikumar, PhD

CONTACT

7137431637; aravikum@central.UH.EDU

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 11, 2021
• First Posted: November 26, 2021
• Study Start: November 1, 2021
• Primary Completion: March 1, 2024
• Study Completion: December 1, 2024
• Last Updated: November 26, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share