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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01582880 |
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Date of registration:
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10/04/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Use of Cross-linked Donor Corneas as Carriers for the Boston Keratoprosthesis
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Scientific title:
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The Use of Riboflavin/Ultraviolet A Cross-linked Human Donor Corneas as Carriers for the Boston Keratoprosthesis |
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Date of first enrolment:
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March 2012 |
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Target sample size:
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1 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01582880 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Joseph Ciolino, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Massachusetts Eye and Ear Infirmary |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Other Autoimmune Diseases
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Chemical Injuries
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Lupus Erythematosus, Systemic
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Stevens Johnson Syndrome
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Autoimmune Diseases
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Ocular Cicatricial Pemphigoid
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Unspecified Complication of Corneal Transplant
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Rheumatoid Arthritis
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Intervention(s)
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Drug: Riboflavin
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Primary Outcome(s)
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Changes in Corneal Thickness at 1 Millimeter
[Time Frame: measured at week 4, 6, 26, 32, 52]
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Changes in Corneal Thickness at 2 Millimeter
[Time Frame: measured at week 4, 6, 26, 32, 52]
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Secondary Outcome(s)
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Systemic Safety
[Time Frame: measured at day 1, and week 1, 4, 8, 12, 16, 24, 36, 52]
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Number of Occurrences of Vitritis (Sterile or Infectious) Ulcers
[Time Frame: post op week 52]
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Ocular Safety
[Time Frame: measured at day 1, and week 1, 4, 8, 12, 16, 24, 36, 52]
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Secondary ID(s)
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10-03-020
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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