Customized Contact Lenses

Custom Vision-Corrective Lens Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Keratoconus
• Intervention / Treatment: Device: Customized contact lens

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Geunyoung Yoon, PhD; Phone Number: 7137437860; Email: gyoon2@central.uh.edu
• Study Contact Backup: Name: Ayeswarya Ravikumar, PhD; Phone Number: 7137431637; Email: aravikum@central.UH.EDU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2021
• Primary Completion (Anticipated): March 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: November 11, 2021
• First Submitted That Met QC Criteria: November 23, 2021
• First Posted (Actual): November 26, 2021

Study Record Updates

• Last Update Posted (Actual): November 26, 2021
• Last Update Submitted That Met QC Criteria: November 23, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases; Keratoconus
• Other Study ID Numbers: STUDY00003195

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No