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New treatment option for Keratoconus
Official title Comparison of Epi-ON Corneal Collagen Crosslinking Performed Using an 18-Minute UVA Exposure vs. a 24-Minute UVA Exposure on Eyes With Ectatic Corneal Diseases
ClinicalTrials.gov ID: NCT07124910
What this study is testing
What is Epi-ON corneal cross-linking?
Epi-ON corneal cross-linking is an investigational medicine, being studied as a potential treatment for keratoconus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to study the effects of an experimental (not Food and Drug Administration (FDA)-approved) treatment called corneal crosslinking (CXL) for conditions in which the cornea becomes progressively thin, steep, and misshapen, causing vision to be blurred. CXL is performed by putting riboflavin (vitamin B2) drops onto the eye and then exposing it to ultraviolet (UVA) light at about the same intensity as you get outdoors on a bright, sunny day.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 8 and older
You may be able to join if
- people in whom both the subject and study eye meet all of the following criteria are candidates for the study:
- Be at least 8 years of age or older, male or female, of any race.
- Have a diagnosis of keratoconus, ectasia after LASIK, ectasia after PRK, pellucid marginal degeneration, progressive ectasia after previous CXL...
- Provide written informed consent and a signed HIPAA form. Pediatric people less than 14 years of age must sign an assent, and a parent or legal...
- Be willing and able to follow all instructions and comply with the schedule for follow-up visits.
You likely can't join if
- people in whom the subject or study eye meets one or more of the following criteria will be excluded from the assigned by chance cohort of the study:
- Normal corneal topography.
- A history of previous corneal transplant in the study eye.
- Minimum corneal thickness \< 300 (measured by Pentacam and Ultrasound) at the screening exam.
- Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye to future complications or prevent...
- History of or active corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.)
See the full eligibility criteria
- people in whom both the subject and study eye meet all of the following criteria are candidates for the study:
- Be at least 8 years of age or older, male or female, of any race.
- Have a diagnosis of keratoconus, ectasia after LASIK, ectasia after PRK, pellucid marginal degeneration, progressive ectasia after previous CXL treatment or forme fruste keratoconus based on topography, tomography, and...
- Provide written informed consent and a signed HIPAA form. Pediatric people less than 14 years of age must sign an assent, and a parent or legal guardian must sign an informed consent.
- Be willing and able to follow all instructions and comply with the schedule for follow-up visits.
- If female and capable of becoming pregnant, must not be lactating or pregnant and must agree to use a medically acceptable form of birth control for at least one week prior to the treatment visit and to continue one...
- people in whom the subject or study eye meets one or more of the following criteria will be excluded from the assigned by chance cohort of the study:
- Normal corneal topography.
- A history of previous corneal transplant in the study eye.
- Minimum corneal thickness \< 300 (measured by Pentacam and Ultrasound) at the screening exam.
- Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye to future complications or prevent the possibility of improved vision, for example:
- History of or active corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.)
- Clinically significant corneal scarring in the central cornea that, in the investigator's opinion, will not allow the subject to achieve functional vision, even with contact lens correction, after the crosslinking...
- A known contraindication, sensitivity, or allergy to the test article or its components or to study medications.
- Nystagmus or any other condition that would prevent a steady gaze during the crosslinking treatment or other diagnostic tests.
- If female, pregnant, nursing or planning a pregnancy, or having a positive urine pregnancy test prior to the randomization of, or treatment of either eye during the course of the study.
- Inability to remove soft or scleral contact lenses at least 3 days before initial and follow-up examinations.
- Inability to remove rigid gas-permeable contact lenses at least 2 weeks before initial and follow-up examinations.
- Inability to return for required postoperative examinations.
- Presence or history or any other condition or finding that, in the investigator's opinion, makes the subject unsuitable as a candidate for crosslinking or study participation or may confound the outcome of the study.
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
- Canton, Georgia, United States
- Cumming, Georgia, United States
- Douglasville, Georgia, United States
- Lawrenceville, Georgia, United States
- Marietta, Georgia, United States
- Snellville, Georgia, United States
- Asheville, North Carolina, United States
- Chattanooga, Tennessee, United States
- Johnson City, Tennessee, United States
- Knoxville, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 8 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States; Canton, Georgia, United States; Cumming, Georgia, United States; Douglasville, Georgia, United States; Lawrenceville, Georgia, United States; Marietta, Georgia, United States and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.