Study Status: NOT_YET_RECRUITING
Recruit Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Official Title: A Randomized Clinical Trial of Ex Vivo Corneal Cross-Linking of Donor Keratoplasty Tissue for Keratoconus
Brief Summary: This randomized clinical trial will assess corneal astigmatism and visual outcomes in participants who have undergone corneal transplantation for keratoconus with ex vivo cross-linked donor corneal tissue versus participants who have undergone corneal transplantation for keratoconus with non-cross-linked donor corneas.
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.
Ex vivo crosslinking of donor corneal tissue for patients with keratoconus undergoing PK or DALK could stabilize the cornea and reduce the risk of high astigmatism and improve vision in patient with keratoconus.