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Riboflavin
Corneal Cross-Linking for Keratoconus
Phase 3
Waitlist Available
Led By Nancy A Tanchel, MD
Research Sponsored by Crowd Health Research, LTD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Clinical diagnosis of progressive keratoconus with specific criteria including increase in steepest keratometry value, astigmatism, myopic shift, presence of steepening on topography map, axial topography consistent with keratoconus, and Kmax value ≥ 47.00 D
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial will compare the safety and effectiveness of two ways to do corneal cross-linking, a treatment for a condition that causes the cornea to weaken and change shape.
Who is the study for?
This trial is for people 12 years or older with a condition called keratoconus, where the cornea (the clear front part of the eye) bulges out. They should have worsening vision as shown by certain measurements and be able to follow the study's visit schedule. Those who wear contact lenses must remove them before evaluation and treatment.Check my eligibility
What is being tested?
The study is testing two methods of strengthening the cornea: one where a vitamin B solution (riboflavin) is applied with the outer layer of the cornea intact ('Epithelium-On'), and another method where this layer is removed first ('Epithelium-Off'). Both methods use UV light to activate riboflavin, either in continuous or pulsed beams.See study design
What are the potential side effects?
Possible side effects include discomfort or pain in the eye, temporary blurry vision, swelling, infection risk increase, changes in corneal shape that could affect vision, and sensitivity to light.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My eye condition, keratoconus, is getting worse.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Visual Acuity
Trial Design
4Treatment groups
Active Control
Group I: Epi-Off ContinuousActive Control2 Interventions
Continuous beam of UV light treating cornea without surface epithelium present
Group II: Epi-On ContinuousActive Control2 Interventions
Continuous beam of UV light treating cornea with surface epithelium present
Group III: Epi-Off PulsedActive Control2 Interventions
Pulsed beam of UV light treating cornea without surface epithelium present
Group IV: Epi-On PulsedActive Control2 Interventions
Pulsed beam of UV light treating cornea with surface epithelium present
Find a Location
Who is running the clinical trial?
Crowd Health Research, LTDLead Sponsor
Nancy A Tanchel, MDPrincipal InvestigatorLiberty Laser Eye Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are able and willing to make all of the necessary follow-up appointments.I am 12 years old or older.Your eyesight has changed significantly, making objects appear blurry or out of focus.I do not have eye movements that prevent me from keeping a steady gaze.My condition is delaying skin or tissue healing.I am 12 years old or older with keratoconus.My eye condition, keratoconus, is getting worse.My eye condition is diagnosed as keratoconus.I have had a chemical injury or slow healing in my eye.You need to take off your contact lenses before the evaluation and treatment.You have a steepest keratometry (Kmax) value of ≥ 47.00 D.Your astigmatism has increased by more than 1.00 D in your eye prescription.You have abnormal steepness in the center or bottom of your eye's surface.I have not taken Vitamin C supplements in the week before my treatment.You have an increase of ≥ 1.00 D in the steepest keratometry value.
Research Study Groups:
This trial has the following groups:- Group 1: Epi-Off Continuous
- Group 2: Epi-On Continuous
- Group 3: Epi-Off Pulsed
- Group 4: Epi-On Pulsed
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
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: NCT02095730 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many patients are enrolled in the clinical trial currently?
"Unfortunately, this study is no longer recruiting patients. The listing was originally posted on May 1st, 2014 but has not been updated since March 21st of the same year. There are presently 17 other trials searching for candidates with corneal diseases and 20 studies actively looking for Epi-Off Pulsed participants."
Answered by AI
What medical conditions does Epi-Off Pulsed commonly help alleviate?
"Epi-Off Pulsed can be used to treat dietary and nutritional deficiencies, vitamin insufficiencies, as well as joint pain."
Answered by AI
Are there any other published papers which looked at the effects of Epi-Off Pulsed?
"There are currently 20 trials ongoing for Epi-Off Pulsed, with the majority being in Phase 3. The research locations for this medication are largely centred around San Francisco, though there are a total of 47 sites running these studies."
Answered by AI
Are there different research hospitals running this experiment in town?
"This study is enrolling at Icon Lasik in Denver, Colorado, LaserVue Eye in Santa Rosa, California, Carolina Eye Care in Mt. Pleasant, South carolina as well as other locations."
Answered by AI
Has Epi-Off Pulsed received FDA approval as of yet?
"Given that this is a Phase 3 trial with some evidence of efficacy and multiple rounds of safety data, our team at Power has rated the Epi-Off Pulsed as having a safety score of 3."
Answered by AI
Who else is applying?
What state do they live in?
Utah
Other
Nevada
Texas
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
0
What site did they apply to?
Eye Consultants of Atlanta
Midwest Center for Sight
LASIK of Nevada
Other
Why did patients apply to this trial?
I have keratoconus. I want to see better. I have the customized contact lenses but haven't tried any medications.
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 am Daniel's mother, and we are desperate for treatment. We don't have medical insurance and treatment is very expensive. I am the only one supporting Daniel. There is no cure and within 2-3 years he has gone from mild to now moderate severe. He is limited on what he can do for employment and has been denied disability. He has to put his cellphone 2 inches from his eyes and cannot see past 5 feet in front of him. He depends on rides to get around. We really need help!
PatientReceived no prior treatments
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