Vision Restoration With a Collagen Crosslinked Boston Keratoprosthesis Unit
A Phase I/II Prospective, Randomized, Multicenter, Double-Masked, Vehicle-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Corneal Collagen Cross-Linking of Keratoprosthesis Carrier Tissue in High-Risk Keratoprosthesis Implantation
1 other identifier
interventional
76
1 country
13
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2017
Longer than P75 for phase_1
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 1, 2016
CompletedFirst Posted
Study publicly available on registry
August 11, 2016
CompletedStudy Start
First participant enrolled
March 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2021
CompletedResults Posted
Study results publicly available
May 10, 2023
CompletedMay 10, 2023
April 1, 2023
4.3 years
June 1, 2016
August 4, 2022
April 17, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time From Surgery to Device Loss or Replacement
If the device fails after surgery the time and reason behind the failure will be recorded. The number of device losses in the control group will be compared to the number of device losses in investigational group.
2 years
Secondary Outcomes (4)
Number of Participants With Kpro Retention at 12 Months
Twelve months
Number of Cumulative Delayed Epithelial Healing Events at Day 30
30 days
Median Time From Surgery to Retroprosthetic Membrane Treatment in Days (Laser or Surgical Interventions)
2 years
Median Time From Surgery to Occurrence of Vitritis (Sterile or Infectious)
2 years
Study Arms (2)
Active Treatment Arm
EXPERIMENTALDe-epithelialized corneas cross-linked with riboflavin 0.1% and dextran 20% solution AND ultraviolet A light (UVA Light Source).
Control Treatment Arm
ACTIVE COMPARATORDe-epithelialized corneas will be exposed to only riboflavin 0.1% with dextran 20% solution (NO ultraviolet A light).
Interventions
Riboflavin, a water soluble vitamin, is an essential nutrient and a natural component of many foods.
Dextran is used to increase the viscosity of the solution.
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.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Joseph B. Ciolino, MDlead
- United States Department of Defensecollaborator
Study Sites (13)
The Jules Stein Eye Institute
Los Angeles, California, 90095-7003, United States
UC Davis Health System Eye Center
Sacramento, California, 95817, United States
Shiley Eye Institute, University of California, San Diego
San Diego, California, 92093, United States
Bascom Palmer eye Institute
Miami, Florida, 33136, United States
Illinois Eye and Ear Infirmary
Chicago, Illinois, 60612, United States
Cincinnati Eye Institute
Edgewood, Kentucky, 41017, United States
Wilmer Eye Institute
Baltimore, Maryland, 21287, United States
W.K. Kellogg Eye Center
Ann Arbor, Michigan, 48105, United States
Tauber Eye Center
Kansas City, Missouri, 64111, United States
David and Ilene Flaum Eye Institute, University of Rochester
New York, New York, 14642, United States
University Hospitals Eye Institute
Cleveland, Ohio, 44106, United States
Wills Eye
Bala-Cynwyd, Pennsylvania, 19007, United States
Wilford Hall Ambulatory Surgical Center (WHASC)
Lackland Air Force Base, Texas, 78236, United States
Related Publications (1)
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.
PMID: 32557558DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Odeta Dyrmishi & Joseph Ciolino
- Organization
- Massachusetts Eye and Ear
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph B. Ciolino, MD
Massachusetts Eye and Ear Infirmary
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor of Opthalmology
Study Record Dates
First Submitted
June 1, 2016
First Posted
August 11, 2016
Study Start
March 15, 2017
Primary Completion
June 30, 2021
Study Completion
August 31, 2021
Last Updated
May 10, 2023
Results First Posted
May 10, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share
The data within StudyTrax will be extracted at the completion of the study. This data will be held in a secure network file at MEEI for at least two years following a marketing application submission to the FDA or longer, if required by the MEEI IRB.