Use of Cross-linked Donor Corneas as Carriers for the Boston Keratoprosthesis
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ClinicalTrials.gov Identifier: NCT01582880 |
Recruitment Status
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Completed
First Posted
: April 23, 2012
Results First Posted
: July 24, 2017
Last Update Posted
: September 18, 2017
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Sponsor:
Joseph B. Ciolino, MD
Information provided by (Responsible Party):
Joseph B. Ciolino, MD, Massachusetts Eye and Ear Infirmary
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Tracking Information | ||||
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First Submitted Date ICMJE | April 10, 2012 | |||
First Posted Date ICMJE | April 23, 2012 | |||
Results First Submitted Date | March 21, 2017 | |||
Results First Posted Date | July 24, 2017 | |||
Last Update Posted Date | September 18, 2017 | |||
Study Start Date ICMJE | March 2012 | |||
Actual Primary Completion Date | March 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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
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Change History | Complete list of historical versions of study NCT01582880 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Use of Cross-linked Donor Corneas as Carriers for the Boston Keratoprosthesis | |||
Official Title ICMJE | 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 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. | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 1 Phase 2 |
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Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: Riboflavin
Used to treat donor cornea before implantation
Other Name: Riboflavin (vitamin B2) 0.1% solution |
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Study Arms | 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 |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
1 | |||
Original Estimated Enrollment ICMJE |
10 | |||
Actual Study Completion Date | March 2014 | |||
Actual Primary Completion Date | March 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01582880 | |||
Other Study ID Numbers ICMJE | 10-03-020 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement |
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Responsible Party | Joseph B. Ciolino, MD, Massachusetts Eye and Ear Infirmary | |||
Study Sponsor ICMJE | Joseph B. Ciolino, MD | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Massachusetts Eye and Ear Infirmary | |||
Verification Date | September 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |