KeratoconusNCT05134909
Customized Contact Lenses
A study testing Customized contact lens in people with Keratoconus, run by University of Houston.
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). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Keratoconus
- What is being tested?
- Customized contact lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Nov 2021to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Custom Vision-Corrective Lens Study
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.
- Conditions
- Keratoconus
- Being tested
- Customized contact lens
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Customized contact lensDevice
The customized lenses are designed to correct the eye's optical aberrations.
| Study group | Role | What they receive |
|---|---|---|
| Study: Keratoconus | Experimental | Customized contact lenses will be fitted to each study subject based on their own optical defects. Receives: Device: Customized contact lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
Snellen "Tumbling E" method will be used to determine the smallest visible letter that a subject can see.
Measured: 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.
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
- Study startNov 2021 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeratoconusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Geunyoung Yoon, University of Houston
- Investigators
- Geunyoung Yoon, PhD, Principal investigator, University of Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05134909
- Sponsor's protocol ID
- STUDY00003195
- Status last verified
- Nov 2021
- First submitted
- 11 Nov 2021
- Last updated
- 26 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Custom Vision-Corrective Lens Study
- ClinicalTrials.gov ID
- NCT05134909
- Acronym / sponsor ID
- STUDY00003195
- Conditions
- Keratoconus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Study start
- Nov 2021 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 26 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study: Keratoconus | Experimental | Device: Customized contact lensCustomized contact lenses will be fitted to each study subject based on their own optical defects. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Customized contact lensThe customized lenses are designed to correct the eye's optical aberrations. | Device | Study: Keratoconus |
Primary outcome
Visual acuity
Time frame: up to 2 months
Snellen "Tumbling E" method will be used to determine the smallest visible letter that a subject can see.
Contrast sensitivity
Time frame: up to 2 months
Light and dark sinusoidal stripes (Gabor gratings) will used to determine the smallest contrast that a subject can see.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2021.
- Individual participant dataSharing planned: No
Related trials for Keratoconus
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Proof-of-Concept for a Novel Optical Aperture Contact Lens in Presbyopia and Keratoconus
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A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia
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Enrolling by invitationObservational study
Corneal Biomechanical Analysis Using Brillouin Microscopy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geunyoung Yoon, PhD principal investigator
University of Houston
Questions about this trial
What is this clinical trial studying?
A study testing Customized contact lens in people with Keratoconus, run by University of Houston.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Geunyoung Yoon, PhD (7137437860, gyoon2@central.uh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity (time frame: up to 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2021.