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Collagen Crosslinking Agent
Corneal Collagen Crosslinking for Keratoconus (CXL Trial)
Phase 3
Recruiting
Led By Steven A Greenstein, MD
Research Sponsored by Cornea and Laser Eye Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Axial topography consistent with keratoconus or post-surgical corneal ectasia
12 years of age or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
CXL Trial Summary
This trial will test if corneal crosslinking using two different riboflavin formulations can improve keratoconus or corneal ectasia.
Who is the study for?
This trial is for people aged 12 or older with keratoconus or corneal ectasia, who can remove their contact lenses a week before testing and attend follow-up visits. Pregnant individuals, those with thin corneas, previous eye conditions that may cause complications, or sensitivity to study medications cannot participate.Check my eligibility
What is being tested?
The trial tests the safety and effectiveness of two isotonic riboflavin solutions in reducing corneal curvature through corneal collagen crosslinking (CXL) in patients with keratoconus or post-surgical corneal ectasia.See study design
What are the potential side effects?
Potential side effects are not detailed here but generally could include discomfort at the treatment site, changes in vision, eye irritation or inflammation. Specific risks will be discussed prior to consent.
CXL Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition is related to a cone-shaped cornea or corneal thinning after surgery.
Select...
I am 12 years old or older.
Select...
I have been diagnosed with keratoconus or corneal ectasia after eye surgery.
CXL Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum keratometry
Secondary outcome measures
Visual acuity
CXL Trial Design
2Treatment groups
Active Control
Group I: CXL using Riboflavin/Dextran solutionActive Control1 Intervention
Corneal collagen crosslinking using 0.1% riboflavin mixed with 20% dextran
Group II: CXL usinng Riboflavin/Methylcellulose solutionActive Control1 Intervention
Corneal collagen crosslinking using 0.1% riboflavin mixed with 1.0% hydroxypropylmethylcellulose ( HPMC)
Find a Location
Who is running the clinical trial?
Cornea and Laser Eye InstituteLead Sponsor
9 Previous Clinical Trials
943 Total Patients Enrolled
9 Trials studying Keratoconus
943 Patients Enrolled for Keratoconus
Peter S Hersh, MDStudy DirectorCornea and Laser Eye Institute Hersh Vision Group
4 Previous Clinical Trials
343 Total Patients Enrolled
4 Trials studying Keratoconus
343 Patients Enrolled for Keratoconus
Steven A Greenstein, MDPrincipal InvestigatorCornea and Laser Eye Institute, Hersh Vision Group
2 Previous Clinical Trials
170 Total Patients Enrolled
2 Trials studying Keratoconus
170 Patients Enrolled for Keratoconus
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My condition is related to a cone-shaped cornea or corneal thinning after surgery.I am 12 years old or older.I have removed my contact lenses for a week before the eye test.I do not have any conditions like nystagmus that would prevent me from keeping my gaze steady during treatments.I have been diagnosed with keratoconus or corneal ectasia after eye surgery.I have had a chemical injury or slow healing in my eye.I have had eye conditions or diseases that could complicate future treatments.
Research Study Groups:
This trial has the following groups:- Group 1: CXL using Riboflavin/Dextran solution
- Group 2: CXL usinng Riboflavin/Methylcellulose solution
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Keratoconus Patient Testimony for trial: Trial Name: NCT04897503 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the most extensive sample size for this research?
"That is correct. The clinical trial, which was first posted on April 16th 2021 and last updated on August 23rd 2021, is still recruiting patients. There is a need for 170 individuals across 1 location."
Answered by AI
What condition does CXL usinng Riboflavin/Methylcellulose solution most often help alleviate?
"CXL, which is a Riboflavin/Methylcellulose solution, has numerous potential applications. These include but are not limited to the treatment of vitamin deficiency and joint pain as well as being used as part of a dietary or nutritional therapy"
Answered by AI
Are there any other related studies to this one that use a Riboflavin/Methylcellulose solution?
"There are currently 20 ongoing clinical trials investigating the efficacy of CXL usinng Riboflavin/Methylcellulose solution. Of these, 11 are in Phase 3. The majority of these trials taking place in San Francisco, California; however, there are 47 research sites total for CXL usinng Riboflavin/Methylcellulose solution across the United States."
Answered by AI
Are there any risks associated with CXL treatment that uses Riboflavin/Methylcellulose solution?
"CXL utilising Riboflavin/Methylcellulose solution has received a safety score of 3. This is due to the presence of data supporting efficacy and multiple rounds of data supporting safety, as this trial is in Phase 3."
Answered by AI
Who else is applying?
What state do they live in?
Missouri
Virginia
New York
What site did they apply to?
Cornea and Laser Eye Institue - Hersh Vision Group
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
0
What questions have other patients asked about this trial?
Am I still eligible even if I don’t live in NJ?
PatientReceived no prior treatments
Why did patients apply to this trial?
I’ve been told corneal transplantation is my only option but I have chosen to wait out until other treatments were available.
PatientReceived no prior treatments
I have progressive Keratoconus and received corneal cross linking in my left eye. Upon further testing I have been referred to treat my right eye. Expense is a concern. I want to help others with my condition to prevent further issues and prevent a corneal transplant in my future.
PatientReceived no prior treatments
I have been diagnosed with Keratoconus. I am planning on getting cross linking done. I have an appointment on Wednesday of this week to come to the teaneck office, however, I may cancel as I think I have decided on another doctor. I was wondering if I could get into a trial and what that might entail. I am starting college in September. I am planning on getting my first crosslinking done during one of my breaks this semester, either around Columbus Day or Thanksgiving so as not to interfere with school too much.
PatientReceived 2+ prior treatments
How responsive is this trial?
Most responsive sites:
- Cornea and Laser Eye Institue - Hersh Vision Group: < 24 hours
Average response time
- < 1 Day
Typically responds via
Email
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