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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Massachusetts Eye and Ear Infirmary

Current Primary Outcome: Changes in corneal thickness [ Time Frame: measured at week 1, 4, 8, 12, 16, 24, 36, 52 ]

Corneal thickness measured by OCT at 1, 3, 6, and 12 o'clock surrounding the K-Pro front plate


Original Primary Outcome: Changes in corneal thickness [ Time Frame: measured at day 1, and week 1, 4, 8, 12, 16, 24, 36, 52 ]

Corneal thickness measured by OCT at 1, 3, 6, and 12 o'clock surrounding the K-Pro front plate


Current Secondary Outcome:

  • Lack of sterile ulcers via slit lamp [ Time Frame: post op day 1, week 1, 4, 8, 12, 16, 24, 36, 52. ]
  • Ocular safety [ Time Frame: measured at day 1, and week 1, 4, 8, 12, 16, 24, 36, 52 ]
    incidence and severity of ocular adverse events during the study (ophthalmic examination, adverse events spontaneously reported)
  • Systemic safety [ Time Frame: measured at day 1, and week 1, 4, 8, 12, 16, 24, 36, 52 ]
    incidence and severity of systemic adverse events during the study (clinical laboratory, adverse events spontaneously reported).


Original Secondary Outcome: Same as current

Information By: Massachusetts Eye and Ear Infirmary

Dates:
Date Received: April 10, 2012
Date Started: March 2012
Date Completion: December 2017
Last Updated: March 8, 2017
Last Verified: September 2016