Study comparing vision restoration with collagen cross-linked donor cornea and standard donor cornea

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"Boston Keratoprosthesis surgery study (cornea transplant for patients not candidates for traditional corneal transplant)"
Age: 18 to 100 years old
Healthy Volunteers: No
Keywords: cornea, corneal melting, keratolysis, eye
Type: Drug study, Phase I/II
The Boston Keratoprosthesis is used in patients who are not candidates for a traditional corneal transplant. This could be because they have had a previous failed corneal transplant or have high likelihood for transplant failure due to a large amount of blood vessels in the cornea. The Boston Keratoprosthesis is assembled using a donated cornea tissue. The donated tissue can thin out in certain patients. Studies have shown that cross-linked corneas are broken down more slowly than corneas that have not been cross-linked. In this study patient will either receive a cross-linked donor cornea before Boston Keratoprosthesis surgery or will receive a standard-of-care non-cross-linked donor cornea. Randomization is like flipping a coin – neither patient, nor physician will know which treatment was received. In either scenario, the donor cornea will be delivered to the surgeon by Tissue Bank International (TBI) at the time of the surgery. The cross-linking procedure has not yet been approved by the United States Food and Drug Administration (FDA) and is therefore considered experimental. The cornea contains a protein called collagen that normally provides stability to the cornea (like the steel beams within a tall building). In this study, we will attempt to form extra connections between the collagen strands to make the cornea tissue stronger before it is used for the Boston Keratoprosthesis implantation. The extra connections, called “cross-links,” are formed by treating the cornea tissue with a special Riboflavin (Vitamin B2) with dextran solution and then carefully exposing it to a measured amount of ultraviolet light. Our goal is to get an indication whether this cross-linking treatment may reduce the rate of cornea thinning or melting.
This study requires

Screening visit for eye exam, pregnancy test if applicable Boston Keratoprosthesis surgery (corneal transplant for those who are not candidates for traditional corneal transplant) with either: standard donor cornea or a experimental cross-linked (reinforced between collagen strands) for strength Follow- up visits: Day 1 Week 1, 4, 16, 24, 36, 52, 78 and 104

Who can participate

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

Study duration and period
2 years
Recruitment period
From Jan. 4, 2017
UC Davis Eye Center
4860 Y Street
Suite 2400
Sacramento, CA 95817
Mark Mannis, MD
Research Topic
  • Keratolysis

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