Cross Linking for Corneal Transplant

(ExCrossV Trial)

Recruiting at 9 trial locations

Overseen By Nikolay Boychev, OD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Massachusetts Eye and Ear Infirmary

Must not be taking: Systemic immunosuppressives

Disqualifiers: Stevens-Johnson syndrome, Ocular pemphigoid, Uncontrolled glaucoma, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate post-surgery

96 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Corneal Donor Tissue with Cross Linking?

Research shows that corneal cross-linking (CXL) can strengthen the cornea by improving its biomechanical properties, as seen in studies with different CXL protocols. This suggests that treating corneal donor tissue with CXL could potentially enhance the durability and stability of corneal transplants. ^{1 2 3 4 5}

Is corneal cross-linking safe for humans?

Research shows that corneal cross-linking, a procedure that strengthens the cornea using riboflavin (a type of vitamin B) and ultraviolet light, is generally safe. Studies have evaluated its safety for various eye conditions, and while some early post-operative complications can occur, it is considered safe in the long term. ^{6 7 8 9 10}

How is the treatment of corneal donor tissue with cross-linking different from other treatments for corneal transplants?

This treatment is unique because it involves strengthening the donor corneal tissue before transplantation using a process called cross-linking, which helps to reduce the risk of graft failure and improve the stability of the transplant. ^{1 2 11 12 13}

What is the purpose of this trial?

The main objective of this study is to determine the safety of Ex Vivo Cross Linking (CXL) of donor corneal tissue in participants who have undergone high-risk penetrating keratoplasty.

Research Team

Joseph Ciolino, MD

Principal Investigator

Massachusetts Eye and Ear

Eligibility Criteria

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

Willing and able to provide written informed consent

Willing and able to comply with study assessments for the full duration of the study

I need a high-risk cornea transplant due to significant blood vessel growth.

Exclusion Criteria

I haven't changed my steroid cream use in the last 2 weeks.

I have glaucoma that is not well-managed.

Participation in another simultaneous medical investigation or trial

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either treated or untreated corneal tissue for high-risk penetrating keratoplasty

Immediate post-surgery

Follow-up

Participants are monitored for safety and effectiveness after transplantation, including ocular safety and graft rejection

24 months

Treatment Details

Interventions

• Corneal Donor Tissue with Cross Linking

Trial Overview The trial is testing if treating donor corneas with Ex Vivo Cross Linking (CXL) before transplantation is safe compared to using untreated donor tissue. Participants are those undergoing high-risk penetrating keratoplasty.

Participant Groups

Group I: Participants Receiving Treated Cross Linked Corneal Tissue Experimental Treatment 1 Intervention

Participants in this group will receive tissue that has been treated with 0.1% riboflavin (Vitamin B2) and 20% dextran (Photrexa® viscous and Photrexa®) with UV light treatment. Participants will be monitored over a period of 24 months.

Group II: Participants Receiving Untreated Cross Linked Corneal Tissue Placebo Group 1 Intervention

Participants in this group will receive tissue that has has not been treated with 0.1% riboflavin (Vitamin B2) and 20% dextran (Photrexa® viscous and Photrexa®) without UV light treatment. Participants will be monitored over a period of 24 months.

Who Is Running the Clinical Trial?

Massachusetts Eye and Ear Infirmary

Lead Sponsor

Trials

115

Recruited

15,000+

Findings from Research

Corneal cross-linking (CXL) has been established as a safe and effective treatment for keratoconus and corneal ectasias, supported by numerous laboratory and clinical studies.

Recent research is paving the way for advancements in CXL techniques, including accelerated methods and epithelium-sparing protocols, which may enhance treatment outcomes and broaden the applications of CXL.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current and future applications of corneal cross-linking. Khandelwal, SS., Randleman, JB.[2018]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Combining Porcine Xenograft Intra-Corneal Ring Segments and CXL: a Novel Technique. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Morphological modification of the cornea after standard and transepithelial corneal cross-linking as imaged by anterior segment optical coherence tomography and laser scanning in vivo confocal microscopy. [2013]

3. United States pubmed.ncbi.nlm.nih.gov

Use of Nanoindentation in Determination of Regional Biomechanical Properties of Rabbit Cornea After UVA Cross-Linking. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Corneal Biomechanical Evaluation After Conventional Corneal Crosslinking With Oxygen Enrichment. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Oxygen Diffusion May Limit the Biomechanical Effectiveness of Iontophoresis-Assisted Transepithelial Corneal Cross-linking. [2019]

6. New Zealand pubmed.ncbi.nlm.nih.gov

The Safety Profile of FDA-Approved Epithelium-Off Corneal Cross-Linking in a US Community-Based Healthcare System. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Superficial corneal crosslinking during laser in situ keratomileusis. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Corneal cross-linking and safety issues. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Corneal Cross-linking to Halt the Progression of Keratoconus and Corneal Ectasia: Seven-Year Follow-up. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Corneal Crosslinking With Rose Bengal and Green Light: Efficacy and Safety Evaluation. [2017]

11. United States pubmed.ncbi.nlm.nih.gov

Penetrating keratoplasty using collagen crosslinked donor tissue: A case report. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Current and future applications of corneal cross-linking. [2018]

13. New Zealand pubmed.ncbi.nlm.nih.gov

Adjuvant corneal crosslinking to prevent hyperopic LASIK regression. [2022]