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

Joseph B. Ciolino, MD

Status and phase: Completed; Phase 2; Phase 1

Conditions: Lupus Erythematosus, Systemic; Other Autoimmune Diseases; Unspecified Complication of Corneal Transplant; Ocular Cicatricial Pemphigoid; Chemical Injuries; Rheumatoid Arthritis; Stevens Johnson Syndrome; Autoimmune Diseases

Treatments: Drug: Riboflavin

Study type: Interventional

Funder types: Other

Identifiers

NCT01582880

10-03-020

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Riboflavin Cross-linked donor cornea

Experimental group

Description:

the donor cornea used as a carrier for the Boston Keratoprosthesis will undergo crosslinking treatment before being trephined and prepared for implantation with the Keratoprosthesis.

Treatment:

Drug: Riboflavin