The Cornea and Laser Eye Institute has completed enrollment for this study. Please continue to check back for additional studies available for the treatment of Keratoconus
Keratoconus is a naturally occurring ocular condition in which the cornea (clear front part of the eye) thins and becomes cone-shaped causing visual problems.
We are pleased to announce a new research study for patients who are suffering from Progressive Keratoconus. The study is being conducted at The Cornea and Laser Eye Institute and several other clinics across the U.S.
Participation in this study would last approximately 12 months after treatment, but may last approximately 18 months if your other eye is eligible and you decide to have your other eye treated.
- The study will require approximately eight (8) study visits to our office, including a screening visit, to determine if you are eligible to participate.
- You may be eligible for this study if you are at least 12 years old and have a diagnosis of progressive Keratoconus.
- The goal of this research procedure is to strengthen the cornea and delay the progressive disease Keratoconus through corneal collagen cross-linking.
If you qualify for the study, you will be assigned by chance or random (like the flip of a coin) to either the cross-linking treatment or the placebo group:
- If you are randomized to receive the cross-linking treatment in your study eye, your non-study eye may receive cross-linking treatment from the 3 month visit to the 6 month visit, as long as all eligibility requirements continue to be met.
- If you are randomized to Placebo control in your study eye and your non-study eye meets eligibility requirements, you may receive cross-linking treatment in your non-study eye at the randomization visit (Day 0) or any time up to the 3 month visit period for the study eye.
- If you are randomized to receive Placebo control treatment in your study eye, you may have your study eye treated with cross-linking treatment within 45 days after the study eye’s Month 6 examination, as long as your study doctor confirms it is your best option.
- The Cross-linking procedure will be provided at no cost to you. However, you may be responsible for costs associated with standard of care or follow-up procedures on your non-study eye.
What is Corneal Collagen Cross-linking?
- The Corneal Collagen Cross-linking procedure uses UV radiation combined with riboflavin (Vitamin B2 ophthalmic solution).
- It is a procedure available in Europe and currently undergoing investigational clinical research in the United States.
- Avedro is currently working on several clinical trials spanning over 100 sites nationwide.
- The primary goal of cross-linking Keratoconus patients is to strengthen and stiffen the corneal fibers in order to decrease the progression of Keratoconus.
- The safety and efficacy of accelerated cross-linking, as yet, is unclear, although results from U.S. and European studies are positive.
Below is a sample of a patient’s pre-operation and one year post-operation eye topography map:
The pre-operation eye shows a cone shape (the red area indicates a steep area, the green/yellow area is flatter). This is an indication of Keratoconus. In the one year post-operation topography reading, the eye has a more regular shape and the cornea is flatter.
The graph below illustrates results from previous Corneal Collagen Cross-linking (CXL) studies. The blue bars show the group that was cross-linked. The average patient’s eye flattened over 1 Diopter (increasing the optical power of the lens), and approximately a 2 Diopter improvement over the placebo group. Since Keratoconus is a progressive disease, you can see how the placebo group continued to progress and worsen by 1 Diopter as the cornea continued to steepen.
The KXL Device
The KXL System is CE marked for accelerated cross-linking and is commercially distributed in all countries that recognize the CE mark. This study will investigate whether pulsing the UVA light will result in more cross-linking. The results from clinical trials in the EU are encouraging.
More than 75,000 patients have been treated worldwide with the KXL System and Avedro’s family of proprietary riboflavin ophthalmic solutions!
Your participation in this study is entirely voluntary. Whether or not you participate in this study will have no effect on the relationship or the quality of care you receive with me or the staff at The Cornea and Laser Eye Institute.
If you are interested in learning more about this study, please contact my Study Coordinator, BethAnn Furlong-Hibbert, at 201-883-0505 or firstname.lastname@example.org. We will be glad to answer any questions you may have regarding this study.
Thank you for your time and consideration. We look forward to hearing from you!