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.
Willing and able to provide written informed consent.
Willing and able to comply with study assessments for the full duration of the study.
Age ≥18 years but ≤50 years
History of keratoconus (without a previous transplant) requiring keratoplasty
Age < 18 years >50
Inability to provide written informed consent and comply with study assessments for the full duration of the study
Participation in another simultaneous interventional medical investigation or trial
History of Stevens-Johnson syndrome or ocular pemphigoid
Joseph B. Ciolino, MD
Lead sponsor
Massachusetts Eye and Ear Infirmary
Sponsor institution