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

NCT ID: NCT01582880

Last Updated: 2019-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2014-03-31

Brief 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).

Detailed 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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Riboflavin Cross-linked donor cornea

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.

Group Type: EXPERIMENTAL

Riboflavin

Intervention Type: DRUG

Used to treat donor cornea before implantation

Interventions

Riboflavin

Used to treat donor cornea before implantation

Intervention Type: DRUG

Other Intervention Names

Riboflavin (vitamin B2) 0.1% solution

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Joseph B. Ciolino, MD

OTHER

Sponsor Role: lead

Responsible Party

Joseph B. Ciolino, MD

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Joseph Ciolino, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts Eye and Ear Infirmary

Locations

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

10-03-020

Identifier Type: -

Identifier Source: org_study_id