Use of Cross-linked Donor Corneas as Carriers for the Boston Keratoprosthesis

The corneal cross-linking technique has been shown to strengthen the cornea and resist
degradation by the body's own enzymes. The use of highly-resistant donor corneas is meant to
eliminate the serious post-operative complication of corneal melting (keratolysis) that
repeatedly occurs in Boston KPro patients with severe ocular burns, autoimmune and
cicatrizing diseases.

Inclusion Criteria:

1. Ability to provide written informed consent and comply with study assessments for the
full duration of the study.

2. Age > 18 years.

3. A negative urine pregnancy test.

4. Candidate for a Boston Keratoprosthesis/Corneal transplant.

5. Generally good stable overall health.

6. Patients with an eye at risk for a cornea sterile ulcer which includes:

- Chemical injuries.

- Autoimmune diseases (ocular cicatricial pemphigoid, Stevens Johnson Syndrome,
systemic lupus erythematosus, rheumatoid arthritis, or other autoimmune
diseases).

- History of previous sterile corneal ulceration requiring a cornea transplant.

Exclusion Criteria:

1. Age < 18 years.

2. Inability to provide written informed consent and comply with study assessments for
the full duration of the study.

3. Pregnant or lactating women.

4. No or minimal tear production.

5. Ocular or periocular malignancy.

6. Inability to wear a contact lens due to lid abnormalities or shortened fornix.

7. Signs of current infection, including fever and current treatment with antibiotics.

8. Participation in another simultaneous medical investigation or trial