Safety and Effectiveness of the UV-X System for Corneal Collagen Cross-Linking in Eyes With Refra… (NCT02068430) | Clinical Trial Compass
CompletedPhase 1
Safety and Effectiveness of the UV-X System for Corneal Collagen Cross-Linking in Eyes With Refractory Corneal Infection
United States6 participantsStarted 2008-11
Plain-language summary
This study will evaluate the Safety and Effectiveness of the UV-X System for Corneal Collagen Cross-Linking in Eyes with Corneal Infection. The treatment of UV-X system is to use the eyedrops of the riboflavin, also known as vitamin B2, and ultraviolet A (UVA) light. The eye drops are placed in affected eye and then affected cornea is exposed to UVA.
UVA/riboflavin corneal collagen cross-linking was first used to treat patients in 1998 in Dresden, Germany. Data to date obtained mostly by physicians outside the United States has strongly suggested this treatment as an acceptable alternative, and many subjects have had a lasting effect (no progression) 3-5 years after their initial treatment.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subjects who have one eye that meets the following criteria:
* 18 years of age or older
* Having a diagnosis of a corneal ulcer.
* Corneal scraping sent for cultures and sensitivities.
* Having been treated for at least three days with conventional broad spectrum anti infective therapy without improvement
* Showing no response to the therapy by one or more of the following criteria:
* Progressive thinning of cornea
* Increasing diameter of corneal ulcer
* Increasing diameter of corneal infiltrate
* Persistent epithelial defect
* Persistent inflammatory signs as iritis and hypopyon
* Persistent pain
Exclusion Criteria:
* All subjects meeting any of the following criteria will be excluded from this study:
* A corneal ulcer that has perforated
* A corneal ulcer that has produced a descemetocele.
* Women who may be breast-feeding and pregnant women.
* Herpetic infection suggested by history or clinical evaluation.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.