Cross Linking for Corneal Transplant
(ExCrossV Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new method for preparing corneal tissue for individuals who have undergone a corneal transplant and face a high risk of complications. The study compares two groups: one receiving corneal donor tissue with cross-linking, treated with a combination of riboflavin (Vitamin B2) and dextran, followed by UV light, and the other receiving untreated tissue. The primary goal is to assess the safety of this treatment method. Individuals who have had a corneal transplant and are experiencing new blood vessel growth in the cornea may be suitable candidates for this trial. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants an opportunity to contribute to significant advancements in corneal transplant care.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are using systemic immunosuppressive drugs for reasons other than corneal graft rejection, you may not be eligible to participate.
What prior data suggests that Ex Vivo Cross Linking is safe for corneal transplants?
Research shows that corneal cross-linking (CXL) is generally safe, with a low risk of serious problems. Although rare, some possible issues include infections, blurry vision, or corneal scarring, but these are uncommon.
CXL strengthens the cornea (the clear front part of the eye) using a mix of riboflavin (Vitamin B2) and UV light. Most patients tolerate this treatment well. It is commonly used for conditions like keratoconus, which alters the shape of the cornea.
This trial focuses on using CXL with donor corneal tissue. This method resembles current CXL treatments, suggesting it might also be safe. The trial is in Phase 2, indicating some early evidence of safety, but more research is needed for confirmation.12345Why do researchers think this study treatment might be promising?
Researchers are excited about this treatment because it introduces a novel approach to corneal transplants by using cross-linking with riboflavin (Vitamin B2) and UV light. This method aims to strengthen the corneal tissue, potentially reducing the risk of rejection and improving transplant success rates. Unlike traditional corneal transplants, which may not address issues of tissue stability, this cross-linking technique offers a promising way to enhance the durability and integration of donor tissue, providing a more robust solution for patients with corneal conditions.
What evidence suggests that Ex Vivo Cross Linking is effective for corneal transplant?
Research has shown that treating corneal donor tissue outside the body (ex vivo) with a process called cross-linking (CXL) can improve the success of corneal transplants, especially in more challenging cases. In this trial, participants will receive either treated or untreated cross-linked corneal tissue. Studies have found that CXL strengthens the corneal tissue, potentially helping transplanted tissue last longer. This treatment uses a mix of riboflavin (Vitamin B2), a sugar solution called dextran, and UV light to strengthen the cornea. Previous results suggest that this method can stop the progression of conditions like keratoconus, which often leads to the need for a corneal transplant. Overall, early findings indicate that CXL-treated tissue might provide better long-term results for patients receiving corneal transplants.678910
Who Is on the Research Team?
Joseph Ciolino, MD
Principal Investigator
Massachusetts Eye and Ear
Are You a Good Fit for This Trial?
This trial is for adults over 18 who need a high-risk corneal transplant due to significant blood vessel growth into the cornea. They must be able to follow the study plan and not have had recent eye surgery, uncontrolled glaucoma, active uveitis, ocular infections or malignancies, certain systemic diseases like Stevens-Johnson syndrome, or be pregnant.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either treated or untreated corneal tissue for high-risk penetrating keratoplasty
Follow-up
Participants are monitored for safety and effectiveness after transplantation, including ocular safety and graft rejection
What Are the Treatments Tested in This Trial?
Interventions
- Corneal Donor Tissue with Cross Linking
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts Eye and Ear Infirmary
Lead Sponsor