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Customized Contact Lenses

NCT ID: NCT05134909

Last Updated: 2021-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-30

Study Completion Date

2024-12-31

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.

Detailed Description

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Conditions

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Keratoconus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Study: Keratoconus

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

Group Type EXPERIMENTAL

Customized contact lens

Intervention Type DEVICE

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

Interventions

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Customized contact lens

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

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Houston

OTHER

Sponsor Role lead

Responsible Party

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Geunyoung Yoon

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Geunyoung Yoon, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Houston

Central Contacts

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Geunyoung Yoon, PhD

Role: CONTACT

Phone: 7137437860

Email: [email protected]

Ayeswarya Ravikumar, PhD

Role: CONTACT

Phone: 7137431637

Email: [email protected]

Other Identifiers

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STUDY00003195

Identifier Type: -

Identifier Source: org_study_id