ExCrossV Multi Site Trial for Vascularized High Risk Keratoplasty

Conditions

• Corneal Transplant Failure

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Corneal Donor Tissue with Cross Linking — PROCEDURE
  Participants are transplanted with corneal donor tissue that has been treated with 0.1% riboflavin (Vitamin B2) and 20% dextran (Photrexa® Viscous \& Photrexa®) with UV light treatment.
• Corneal Donor Tissue without Cross Linking — PROCEDURE
  Participants are transplanted with corneal donor tissue that has not been treated with the UV light and the 0.1% riboflavin (Vitamin B2) and 20% dextran (Photrexa® Viscous \& Photrexa®) without UV light treatment, this is the control group.

Study Details

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.

Key Dates

Start date

Apr 1, 2025

Status verified

Apr 2026

Primary completion

Jan 1, 2028

Completion

Jan 1, 2031

Study Design

Enrollment

96 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Participants Receiving Treated Cross Linked Corneal Tissue
  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.
• Placebo Comparator: Participants Receiving Untreated Cross Linked Corneal Tissue
  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.

Primary Outcome Measure

Determining the Primary Safety of Corneal Cross Linking [ Time Frame: 24 Months ]

Central Contacts

• Michael Cheung, MSc, CCRP
  6175736060
  [email protected]
• Nikolay Boychev, OD, PhD

Locations (12)

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