Customized Contact Lenses

Keratoconus Clinical Trial

Official title:

Custom Vision-Corrective Lens Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05134909
• Other study ID #: STUDY00003195
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2021
• Est. completion date: December 2024

Study information

• Verified date: November 2021
• Source: University of Houston
• Contact: Geunyoung Yoon, PhD
• Phone: 7137437860
• Email: gyoon2[@]central.uh.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Keratoconus

Intervention

Device:
• Customized contact lens
The customized lenses are designed to correct the eye's optical aberrations.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Houston

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual acuity	Snellen "Tumbling E" method will be used to determine the smallest visible letter that a subject can see.	up to 2 months
Primary	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