Vision Restoration With a Collagen Crosslinked Boston Keratoprosthesis Unit

Completed · Phase 1/Phase 2

Conditions studied: Keratolysis

In brief

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.

Key facts

Study ID

NCT02863809

Run by

Joseph B. Ciolino, MD

People needed

76

Starts

2017-03-15

Expected to finish

2021-08-31

Last updated by the study team

2023-05-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The Jules Stein Eye Institute — Los Angeles, California, United States
• UC Davis Health System Eye Center — Sacramento, California, United States
• Shiley Eye Institute, University of California, San Diego — San Diego, California, United States
• Bascom Palmer eye Institute — Miami, Florida, United States
• Illinois Eye and Ear Infirmary — Chicago, Illinois, United States
• Cincinnati Eye Institute — Edgewood, Kentucky, United States
• Wilmer Eye Institute — Baltimore, Maryland, United States
• W.K. Kellogg Eye Center — Ann Arbor, Michigan, United States
• Tauber Eye Center — Kansas City, Missouri, United States
• David and Ilene Flaum Eye Institute, University of Rochester — New York, New York, United States
• University Hospitals Eye Institute — Cleveland, Ohio, United States
• Wills Eye — Bala-Cynwyd, Pennsylvania, United States
• Wilford Hall Ambulatory Surgical Center (WHASC) — Lackland Air Force Base, Texas, United States

Full record on ClinicalTrials.gov

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