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Corneal Collagen Cross-Linking Techniques for Keratoconus
Phase 3
Waitlist Available
Research Sponsored by Center for Sight, Sacramento, CA
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Having a diagnosis of keratoconus or other corneal ectatic disorder
Axial topography consistent with keratoconus or other corneal ectatic disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 months, and 12 months
Awards & highlights
Study Summary
This trial will compare the safety and effectiveness of two different techniques for corneal cross-linking (CXL) in eyes with keratoconus and other corneal ectatic disorders. Subjects will be randomized to receive the CXL treatment with either the Epi-On or Epi-Off technique.
Who is the study for?
This trial is for individuals at least 12 years old with keratoconus or other corneal ectatic disorders. Participants must provide consent, have specific topography map changes, and be willing to use birth control if applicable. Those with prior CXL treatment, corneal transplants, certain ocular conditions, allergies to study materials, or inadequate corneal thickness are excluded.Check my eligibility
What is being tested?
The study compares two techniques of Corneal Collagen Cross-Linking (CXL) treatments for strengthening the cornea: Epi-OFF (removal of the outer layer of the cornea) and Epi-ON (outer layer left intact), both using Ricrolin+ and VEGA UV-A system in a randomized design.See study design
What are the potential side effects?
Potential side effects may include discomfort or pain in the eye, temporary visual disturbances like blurriness or halos around lights, sensitivity to light, inflammation or swelling of the eye tissues, and delayed healing of the outer layer of the cornea.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with keratoconus or a similar eye condition.
Select...
My eye condition is related to a thinning cornea.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 6 months, and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 months, and 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean change in corneal curvature
Secondary outcome measures
Change in best-corrected visual acuity (BSCVA)
Change in manifest refraction spherical equivalent
Change in thinnest pachymetry
+1 moreTrial Design
2Treatment groups
Active Control
Group I: Epi-ON CXLActive Control2 Interventions
The Epi-OFF treatment will be performed with removal of the corneal epithelium before the first dose of riboflavin is administered. Ricrolin+ will be used as the riboflavin formulation for the pre-treatment and irradiation steps of the Epi-OFF treatments. The VEGA UV-A light will be used during the irradiation steps of the Epi-OFF treatment.
Group II: Epi-OFF CXLActive Control2 Interventions
The Epi-ON treatment will be performed without removal of the corneal epithelium. Ricrolin+will be used as the riboflavin formulation for the pre-treatment and irradiation steps of the Epi-ON treatments. The VEGA UV-A light will be used during the irradiation steps of the Epi-ON treatment.
Find a Location
Who is running the clinical trial?
Center for Sight, Sacramento, CALead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with keratoconus or a similar eye condition.A specific eye treatment technique cannot be used on me, as per my doctor's advice.My eye condition is related to a thinning cornea.My eye's healing could be affected by my medical history or condition.You have had Intacs, corneal rings, or segments implanted in your eye.I am not pregnant, nursing, or planning to become pregnant during the study.I am willing to undergo a corneal cross-linking procedure.I have had a corneal transplant in one of my eyes.I can follow all instructions and attend all scheduled follow-up visits.I do not have any conditions that prevent me from keeping my gaze steady.I have signed the consent forms or, if under 14, my guardian has and I've given my assent.My eyes have no past conditions that could risk surgery or block vision improvement.I have had CXL treatment in the eye being studied.I am 12 years old or older.My eye condition includes signs like Fleischer ring or corneal thinning.
Research Study Groups:
This trial has the following groups:- Group 1: Epi-ON CXL
- Group 2: Epi-OFF CXL
Awards:
This trial has 2 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.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA cleared Epi-ON CXL for use?
"There is available data that supports the safety of Epi-ON CXL, as this is a Phase 3 trial."
Answered by AI
Are we enrolling more people in this experiment right now?
"Unfortunately, this trial is not recruiting patients at the moment. However, this study was most recently edited on February 26th, 2019 and was originally posted on March 8th, 2019. There are other 53 studies that are actively recruiting patients."
Answered by AI
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