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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Massachusetts Eye and Ear Infirmary
Sponsor:
Information provided by (Responsible Party):
Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier:
NCT01582880
First received: April 10, 2012
Last updated: March 20, 2013
Last verified: March 2013

April 10, 2012
March 20, 2013
March 2012
March 2014   (final data collection date for primary outcome measure)
Changes in corneal thickness [ Time Frame: measured at week 1, 4, 8, 12, 16, 24, 36, 52 ] [ Designated as safety issue: No ]
Corneal thickness measured by OCT at 1, 3, 6, and 12 o'clock surrounding the K-Pro front plate
Changes in corneal thickness [ Time Frame: measured at day 1, and week 1, 4, 8, 12, 16, 24, 36, 52 ] [ Designated as safety issue: No ]
Corneal thickness measured by OCT at 1, 3, 6, and 12 o'clock surrounding the K-Pro front plate
Complete list of historical versions of study NCT01582880 on ClinicalTrials.gov Archive Site
  • Lack of sterile ulcers via slit lamp [ Time Frame: post op day 1, week 1, 4, 8, 12, 16, 24, 36, 52. ] [ Designated as safety issue: No ]
  • Ocular safety [ Time Frame: measured at day 1, and week 1, 4, 8, 12, 16, 24, 36, 52 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    incidence and severity of systemic adverse events during the study (clinical laboratory, adverse events spontaneously reported).
Same as current
Not Provided
Not Provided
 
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

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). 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.

Not Provided
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Chemical Injuries
  • Unspecified Complication of Corneal Transplant
  • Autoimmune Diseases
  • Ocular Cicatricial Pemphigoid
  • Stevens Johnson Syndrome
  • Lupus Erythematosus, Systemic
  • Rheumatoid Arthritis
  • Other Autoimmune Diseases
Drug: Riboflavin
Used to treat donor cornea before implantation
Experimental: 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.
Intervention: Drug: Riboflavin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
June 2014
March 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Cornea Research 617-573-3313 cornea_research@meei.harvard.edu
United States
 
NCT01582880
10-03-020
No
Massachusetts Eye and Ear Infirmary
Massachusetts Eye and Ear Infirmary
Not Provided
Principal Investigator: Joseph Ciolino, MD Massachusetts Eye and Ear Infirmary
Massachusetts Eye and Ear Infirmary
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP