Safety and Efficacy of Ex Vivo Corneal Cross-Linking of Donor Corneal Tissue Used For a Penetrating Keratoplasty

• Status: Not yet recruiting
• Trial end date: 2024-01-01

Summary

This research study will assess the safety and efficacy of crosslinking donor corneal tissue in participants who have undergone corneal transplantation for keratoconus. Crosslinking is a procedure that stabilizes the biomechanical properties of the cornea; as a result, the cornea stiffens. It has been shown that this procedure stabilizes the cornea of patients with keratoconus or corneal ectasias. The FDA currently approves crosslinking for patients with progressive keratoconus and corneal ectasia following refractive surgery. Keratoconus has been found to recur in corneas that underwent corneal transplantation. Ex vivo crosslinking of donor corneal tissue for patients with keratoconus undergoing penetrating keratoplasty could stabilize the cornea and reduce the risk of recurrence of keratoconus.

• Phase: Early Phase 1

Details

• Lead Sponsor: Joseph B. Ciolino, MD
• Treatments: Dextrans; Flavin Mononucleotide; Ophthalmic Solutions; Riboflavin