Customized Contact Lenses

Not Applicable

Not yet recruiting

• Conditions: Keratoconus
• Interventions: Device: Customized contact lens

• Registration Number: NCT05134909
• Lead Sponsor: University of Houston

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-11
• Study Start: 2021-11
• Study First Submitted: 2021-11-11
• Study First Submitted QC: 2021-11-23
• Last Update Submitted: 2021-11-23
• Study First Posted: 2021-11-26
• Last Update Posted: 2021-11-26
• Primary Completion: 2024-03
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study: Keratoconus	Customized contact lens	Customized contact lenses will be fitted to each study subject based on their own optical defects.

Primary Outcome Measures

Name	Time	Method
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.
Visual acuity	up to 2 months	Snellen "Tumbling E" method will be used to determine the smallest visible letter that a subject can see.