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

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the pilot study is to test the efficacy and safety of riboflavin/Ultraviolet A (UVA) cross-linked human donor corneas as carriers for the Boston Keratoprosthesis (Boston KPro) in patients with higher risk for corneal melting (keratolysis).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Joseph B. Ciolino, MD; Massachusetts Eye and Ear Infirmary
• Treatments: Riboflavin

Criteria

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