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Customized Contact Lenses

Custom Vision-Corrective Lens Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05134909
Enrollment
60
Registered
2021-11-26
Start date
2021-11-30
Completion date
2024-12-31
Last updated
2021-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keratoconus

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.

Interventions

DEVICECustomized contact lens

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

Sponsors

University of Houston
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Visual acuityup to 2 monthsSnellen Tumbling E method will be used to determine the smallest visible letter that a subject can see.
Contrast sensitivityup to 2 monthsLight and dark sinusoidal stripes (Gabor gratings) will used to determine the smallest contrast that a subject can see.

Contacts

Primary ContactGeunyoung Yoon, PhD
gyoon2@central.uh.edu7137437860
Backup ContactAyeswarya Ravikumar, PhD
aravikum@central.UH.EDU7137431637

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026