Vision Restoration With a Collagen Crosslinked Boston Keratoprosthesis Unit
Launched by JOSEPH B. CIOLINO, MD · Aug 10, 2016
Trial Information
Current as of May 22, 2025
Completed
Keywords
ClinConnect Summary
The study is a multi-center, parallel, randomized, double-blinded study with subsequent follow-up period of two years. Eight-four subjects across twelve sites will be randomized 1:1 to receive either a corneal tissue that have been cross-linked or not cross-linked (No UVA light source). Cross-linking is a term that refers to the linking of polymers (long chain) molecules by chemical bonds. It is believed that cross-linking the cornea will make the cornea stronger and more resistant to degradation.
CorneaGen (formerly Keralink International) (Baltimore site) will supply the donor tissue and...
Gender
ALL
Eligibility 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
About Joseph B. Ciolino, Md
Dr. Joseph B. Ciolino, MD, is a distinguished clinical trial sponsor renowned for his expertise in ophthalmology and innovative approaches to advancing medical research. With a strong commitment to improving patient outcomes, Dr. Ciolino leads clinical trials focused on the development of cutting-edge therapies and technologies in eye care. His research endeavors are characterized by a rigorous adherence to ethical standards and a collaborative spirit, fostering partnerships with healthcare professionals and institutions to drive forward the field of ophthalmic medicine. Through his leadership, Dr. Ciolino aims to contribute significantly to the understanding and treatment of various ocular conditions, ultimately enhancing the quality of life for patients.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Miami, Florida, United States
Baltimore, Maryland, United States
Kansas City, Missouri, United States
Ann Arbor, Michigan, United States
Edgewood, Kentucky, United States
Los Angeles, California, United States
Sacramento, California, United States
San Diego, California, United States
Chicago, Illinois, United States
New York, New York, United States
Cleveland, Ohio, United States
Bala Cynwyd, Pennsylvania, United States
Lackland Air Force Base, Texas, United States
Patients applied
Trial Officials
Joseph B. Ciolino, MD
Principal Investigator
Massachusetts Eye and Ear Infirmary
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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