Vision Restoration With a Collagen Crosslinked Boston Keratoprosthesis Unit
NCT ID: NCT02863809
Last Updated: 2023-05-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
76 participants
INTERVENTIONAL
2017-03-15
2021-08-31
Brief Summary
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Detailed Description
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CorneaGen (formerly Keralink International) (Baltimore site) will supply the donor tissue and Avedro Inc (Waltham MA) will supply the riboflavin and the UV light source. Staff at CorneaGenwill administer the riboflavin with dextran solution and perform the cross-linking procedure according to one of randomization groups before shipping the masked donor cornea to study sites for Boston Keratoprosthesis (B-KPro) implantation.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Active Treatment Arm
De-epithelialized corneas cross-linked with riboflavin 0.1% and dextran 20% solution AND ultraviolet A light (UVA Light Source).
Riboflavin
Riboflavin, a water soluble vitamin, is an essential nutrient and a natural component of many foods.
Dextran
Dextran is used to increase the viscosity of the solution.
UVA Light Source
Avedro's KXL® System is a UVA irradiation system that uses a light emitting diode (LED) to deliver a dose of UVA light to a targeted treatment area for illuminating the cornea during corneal collagen cross-linking.
Control Treatment Arm
De-epithelialized corneas will be exposed to only riboflavin 0.1% with dextran 20% solution (NO ultraviolet A light).
Riboflavin
Riboflavin, a water soluble vitamin, is an essential nutrient and a natural component of many foods.
Dextran
Dextran is used to increase the viscosity of the solution.
Interventions
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Riboflavin
Riboflavin, a water soluble vitamin, is an essential nutrient and a natural component of many foods.
Dextran
Dextran is used to increase the viscosity of the solution.
UVA Light Source
Avedro's KXL® System is a UVA irradiation system that uses a light emitting diode (LED) to deliver a dose of UVA light to a targeted treatment area for illuminating the cornea during corneal collagen cross-linking.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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United States Department of Defense
FED
Joseph B. Ciolino, MD
OTHER
Responsible Party
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Joseph B. Ciolino, MD
Professor of Opthalmology
Principal Investigators
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Joseph B. Ciolino, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts Eye and Ear Infirmary
Locations
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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
Countries
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References
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Davis SA, Bovelle R, Han G, Kwagyan J. Corneal collagen cross-linking for bacterial infectious keratitis. Cochrane Database Syst Rev. 2020 Jun 17;6(6):CD013001. doi: 10.1002/14651858.CD013001.pub2.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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798474
Identifier Type: -
Identifier Source: org_study_id
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