Clinical trial NCT01582880: Use of Cross-linked Donor Corneas as Carriers for the Boston Keratoprosthesis
Official title: The Use of Riboflavin/Ultraviolet A Cross-linked Human Donor Corneas as Carriers for the Boston Keratoprosthesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Chemical Injuries
Unspecified Complication of Corneal Transplant
Autoimmune Diseases
Ocular Cicatricial Pemphigoid
Stevens Johnson Syndrome
Lupus Erythematosus, Systemic
Rheumatoid Arthritis
Other Autoimmune Diseases
Keywords: Keratoprosthesis
sterile cornea ulcer
Lead sponsor: Massachusetts Eye and Ear Infirmary
Sponsor class: OTHER
First posted: 2012-04-23
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes in Corneal Thickness at 1 Millimeter
timeFrame: measured at week 4, 6, 26, 32, 52
measure: Changes in Corneal Thickness at 2 Millimeter
timeFrame: measured at week 4, 6, 26, 32, 52
Secondary outcomes:
measure: Number of Occurrences of Vitritis (Sterile or Infectious) Ulcers
timeFrame: post op week 52
measure: Ocular Safety
timeFrame: measured at day 1, and week 1, 4, 8, 12, 16, 24, 36, 52
measure: Systemic Safety
timeFrame: measured at day 1, and week 1, 4, 8, 12, 16, 24, 36, 52
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts Eye and Ear Infirmary
state: Massachusetts
Study officials:
affiliation: Massachusetts Eye and Ear Infirmary
name: Joseph Ciolino, MD
role: PRINCIPAL_INVESTIGATOR
References: