MedPath

Vision Restoration With a Collagen Crosslinked Boston Keratoprosthesis Unit

Phase 1
Completed
Conditions
Keratolysis
Interventions
Drug: Riboflavin
Drug: Dextran
Device: UVA Light Source
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
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
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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
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Active Treatment ArmUVA Light SourceDe-epithelialized corneas cross-linked with riboflavin 0.1% and dextran 20% solution AND ultraviolet A light (UVA Light Source).
Active Treatment ArmRiboflavinDe-epithelialized corneas cross-linked with riboflavin 0.1% and dextran 20% solution AND ultraviolet A light (UVA Light Source).
Active Treatment ArmDextranDe-epithelialized corneas cross-linked with riboflavin 0.1% and dextran 20% solution AND ultraviolet A light (UVA Light Source).
Control Treatment ArmRiboflavinDe-epithelialized corneas will be exposed to only riboflavin 0.1% with dextran 20% solution (NO ultraviolet A light).
Control Treatment ArmDextranDe-epithelialized corneas will be exposed to only riboflavin 0.1% with dextran 20% solution (NO ultraviolet A light).
Primary Outcome Measures
NameTimeMethod
Time From Surgery to Device Loss or Replacement2 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
NameTimeMethod
Number of Participants With Kpro Retention at 12 MonthsTwelve 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 3030 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

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