NCT01582880

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

The Use of Riboflavin/Ultraviolet A Cross-linked Human Donor Corneas as Carriers for the Boston Keratoprosthesis

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Joseph B. Ciolino, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Riboflavin	Used to treat donor cornea before implantation

Timeline

• Start date: 2012-03-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2012-04-23
• Last updated: 2019-10-21
• Results posted: 2017-07-24

Locations

1 site across 1 country: United States