Purpose of this Study
In this study, people will get a new kind of eye transplant.
They'll be randomly chosen (like flipping a coin) to get either a special treated cornea or a regular one.
Doctors will check on them for 2 years after the transplant to see how they're doing and to watch for any side effects.
Who Can Participate?
Eligibility
Who can join this eye study?
- People who need a special kind of eye surgery called high-risk penetrating keratoplasty
- They must not have certain serious eye diseases like Stevens-Johnson syndrome or ocular pemphigoid
- They cannot have eye cancer or uncontrolled high pressure in the eye (glaucoma)
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
This study is trying to learn more about a new way to treat eye problems.
Doctors are testing if treating donated corneas before surgery helps people with serious eye issues caused by too many blood vessels.
They also want to understand why some people’s corneas get thin and weak.
This research could help make eye transplants safer and more effective.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
MULTICENTER CLINICAL TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF EX VIVO CORNEAL CROSS-LINKING OF DONOR CORNEAL TISSUE USED FOR VASCULARZIED HIGH-RISK KERATOPLASTY - (ExCrossV)
Principal Investigator
Esen
Akpek
Protocol Number
PRO00117573
NCT ID
NCT06753916
Phase
Pilot
Enrollment Status
Pending Open to Enrollment