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
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

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

Criteria

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.

• Age ≥18 years but ≤50 years

• History of keratoconus (without a previous transplant) requiring a penetrating keratoplasty

• Willing to commit to not having further cross-linking, corneal relaxing incisions, intacs, or corneal laser vision correction during the course of the study

Exclusion Criteria:

• 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

Systemic

• History of Stevens-Johnson syndrome or ocular pemphigoid

• Signs of current infection, including fever and current treatment with antibiotics

• Pregnancy (positive pregnancy test) or lactating

• Pre-menopausal sexually active women not using adequate contraception (Reliable intrauterine devices, hormonal contraception or a spermicide in combination with a barrier method)

Recipient Eye

• Corneal or ocular surface infection within 30 days prior to study entry

• History of previous cross-linking

• History of previous corneal transplant

• Non-healing epithelial defect of at least 0.5x0.5 mm in host corneal bed lasting ≥6 weeks preoperatively

• Ocular or periocular malignancy

• Lid abnormalities that in the opinion of the investigator could confound the study results and these include clinically significant ectropion, lagophthalmos, cicatrization, entropion, and rosacea

• Neurotrophic cornea

• Monocular

• Uncontrolled glaucoma

• Glaucoma filtering devices or trabeculectomies