Vision Restoration With a Collagen Crosslinked Boston Keratoprosthesis Unit

• Status: Completed
• Trial end date: 2021-08-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase I/II prospective, randomized, multi-center, double-masked, vehicle-controlled clinical trial evaluating the safety and efficacy of corneal collagen cross-linking the keratoprosthesis carrier tissue in subjects who are candidates for high-risk keratoprosthesis implantation but because of a history of corneal melts or autoimmune diseases are not candidate for a traditional corneal transplant.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Joseph B. Ciolino, MD
• Collaborator: United States Department of Defense
• Treatments: Dextrans; Riboflavin; Vitamins

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

• Candidate for a Boston Keratoprosthesis / Cornea transplant

• In generally good stable overall health

• Patients with an eye at risk for a cornea sterile ulcer which includes:

• Autoimmune diseases (mucus membrane pemphigoid, Stevens-Johnson syndrome, systemic lupus erythematosis, rheumatoid arthritis, or other autoimmune diseases); OR

• History of previous sterile cornea ulceration requiring a cornea transplant

Exclusion Criteria:

• Age < 18 years

• Inability to provide written informed consent and comply with study assessments for the full duration of the study

• No or minimal tear production with evidence of keratinization of the bulbar conjunctiva

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

• Ocular or periocular malignancy

• Inability to wear a contact lens due to lid abnormalities or shortened fornix

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

• Pregnancy (positive pregnancy test) or lactating

• Participation in another simultaneous interventional medical investigation or trial