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Search / Trial NCT02863809

Vision Restoration With a Collagen Crosslinked Boston Keratoprosthesis Unit

Launched by JOSEPH B. CIOLINO, MD · Aug 10, 2016

Trial Information

Current as of May 01, 2025

Completed

Keywords

Keratolysis Corneal Melting Boston K Pro Keratoprosthesis

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.

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

0 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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