Vision Restoration With a Collagen Crosslinked Boston Keratoprosthesis Unit
- Conditions
- Keratolysis
- Interventions
- Registration Number
- NCT02863809
- Lead Sponsor
- Joseph B. Ciolino, MD
- 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.
- Detailed Description
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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 76
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active Treatment Arm UVA Light Source De-epithelialized corneas cross-linked with riboflavin 0.1% and dextran 20% solution AND ultraviolet A light (UVA Light Source). Active Treatment Arm Riboflavin De-epithelialized corneas cross-linked with riboflavin 0.1% and dextran 20% solution AND ultraviolet A light (UVA Light Source). Active Treatment Arm Dextran De-epithelialized corneas cross-linked with riboflavin 0.1% and dextran 20% solution AND ultraviolet A light (UVA Light Source). Control Treatment Arm Riboflavin De-epithelialized corneas will be exposed to only riboflavin 0.1% with dextran 20% solution (NO ultraviolet A light). Control Treatment Arm Dextran De-epithelialized corneas will be exposed to only riboflavin 0.1% with dextran 20% solution (NO ultraviolet A light).
- Primary Outcome Measures
Name Time Method Time From Surgery to Device Loss or Replacement 2 years 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.
- Secondary Outcome Measures
Name Time Method Number of Participants With Kpro Retention at 12 Months Twelve months The number of participants that retained kpro devices at the end of twelve months will be studied and differences in retention rate between investigational and control groups will be reported
Number of Cumulative Delayed Epithelial Healing Events at Day 30 30 days The number of incidences of delayed epithelial healing at day 30 will be recorded. If there is delayed epithelial healing at day 30 it will be determined if those incidences occurred more often in the control group versus the investigational group.
Median Time From Surgery to Retroprosthetic Membrane Treatment in Days (Laser or Surgical Interventions) 2 years If follow up surgery is needed to replace or treat the prosthetic the time and reason will be recorded and the number of incidences will be compared between the study treatment groups
Median Time From Surgery to Occurrence of Vitritis (Sterile or Infectious) 2 years The time (days) and number of incidences of vitritis will be recorded for the subject in which it occurred and the number of incidences will be compared between the study treatment groups.
Trial Locations
- Locations (13)
UC Davis Health System Eye Center
🇺🇸Sacramento, California, United States
The Jules Stein Eye Institute
🇺🇸Los Angeles, 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
W.K. Kellogg Eye Center
🇺🇸Ann Arbor, Michigan, United States
Wilmer Eye Institute
🇺🇸Baltimore, Maryland, 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
Wills Eye
🇺🇸Bala-Cynwyd, Pennsylvania, United States
Wilford Hall Ambulatory Surgical Center (WHASC)
🇺🇸Lackland Air Force Base, Texas, United States
University Hospitals Eye Institute
🇺🇸Cleveland, Ohio, United States