Use of Cross-linked Donor Corneas as Carriers for the Boston Keratoprosthesis
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2013 by Massachusetts Eye and Ear Infirmary.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Massachusetts Eye and Ear Infirmary
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
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
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 |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Use of Riboflavin/Ultraviolet A Cross-linked Human Donor Corneas as Carriers for the Boston Keratoprosthesis |
Resource links provided by NLM:
Genetics Home Reference related topics:
Stevens-Johnson syndrome/toxic epidermal necrolysis
rheumatoid arthritis
Drug Information available for:
Riboflavin
Genetic and Rare Diseases Information Center resources:
Bullous Pemphigoid
Stevens-Johnson Syndrome
Cicatricial Pemphigoid
Ocular Cicatricial Pemphigoid
Erythema Multiforme
U.S. FDA Resources
Further study details as provided by Massachusetts Eye and Ear Infirmary:
Primary Outcome Measures:
- 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
Secondary Outcome Measures:
- 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).
| Estimated Enrollment: | 10 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Drug: Riboflavin
Used to treat donor cornea before implantation
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Ability to provide written informed consent and comply with study assessments for the full duration of the study.
- Age > 18 years.
- A negative urine pregnancy test.
- Candidate for a Boston Keratoprosthesis/Corneal transplant.
- Generally good stable overall health.
-
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:
- Age < 18 years.
- Inability to provide written informed consent and comply with study assessments for the full duration of the study.
- Pregnant or lactating women.
- No or minimal tear production.
- Ocular or periocular malignancy.
- Inability to wear a contact lens due to lid abnormalities or shortened fornix.
- Signs of current infection, including fever and current treatment with antibiotics.
- Participation in another simultaneous medical investigation or trial
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01582880
Please refer to this study by its ClinicalTrials.gov identifier: NCT01582880
Contacts
| Contact: Cornea Research | 617-573-3313 | cornea_research@meei.harvard.edu |
Locations
| United States, Massachusetts | |
| Massachusetts Eye and Ear Infirmary | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Cornea Research 617-573-3313 cornea_research@meei.harvard.edu | |
| Principal Investigator: Joseph Ciolino, MD | |
Sponsors and Collaborators
Massachusetts Eye and Ear Infirmary
Investigators
| Principal Investigator: | Joseph Ciolino, MD | Massachusetts Eye and Ear Infirmary |
More Information
| Responsible Party: | Massachusetts Eye and Ear Infirmary |
| ClinicalTrials.gov Identifier: | NCT01582880 History of Changes |
| Other Study ID Numbers: | 10-03-020 |
| Study First Received: | April 10, 2012 |
| Last Updated: | March 20, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Massachusetts Eye and Ear Infirmary:
|
Keratoprosthesis sterile cornea ulcer |
Additional relevant MeSH terms:
|
Arthritis, Rheumatoid Autoimmune Diseases Pemphigoid, Bullous Lupus Erythematosus, Systemic Stevens-Johnson Syndrome Pemphigoid, Benign Mucous Membrane Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Immune System Diseases Skin Diseases, Vesiculobullous Skin Diseases Stomatitis |
Mouth Diseases Stomatognathic Diseases Drug Eruptions Dermatitis Erythema Multiforme Erythema Drug Hypersensitivity Hypersensitivity Drug-Related Side Effects and Adverse Reactions Chemically-Induced Disorders Conjunctival Diseases Eye Diseases Riboflavin Vitamin B Complex Vitamins |
ClinicalTrials.gov processed this record on September 28, 2016