Customized Contact Lenses

Study Overview
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Brief Summary
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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.

Official Title
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Custom Vision-Corrective Lens Study

Conditions
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Keratoconus

Intervention / Treatment
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* Device: Customized contact lens


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study: Keratoconus<br>Customized contact lenses will be fitted to each study subject based on their own optical defects. | Device: Customized contact lens<br>* The customized lenses are designed to correct the eye's optical aberrations.<br>|

What is the study measuring?
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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 |