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

Tracking Information
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; (submitted: June 28, 2017)	Changes in Corneal Thickness at 1 Millimeter [ Time Frame: measured at week 4, 6, 26, 32, 52 ]The average carrier graft thickness over the first year of postoperative follow-up. The corneal thickness was measured at each visit using AS-OCT imaging 1 mm away from the KPro stem at 3, 6, 9, and 12 o'clock. The individual corneal thickness measurements (3, 6, 9, and 12 o'clock) where then averaged. The average corneal thickness measurements for week 4, 6, 26, 32 and 52 are reported below.; Changes in Corneal Thickness at 2 Millimeter [ Time Frame: measured at week 4, 6, 26, 32, 52 ]The average carrier graft thickness over the first year of postoperative follow-up. The corneal thickness was measured at each visit using AS-OCT imaging 2 mm away from the KPro stem at 3, 6, 9, and 12 o'clock. The individual corneal thickness measurements (3, 6, 9, and 12 o'clock) where then averaged. The average corneal thickness measurements for week 4, 6, 26, 32 and 52 are reported below.
Original Primary Outcome Measures ICMJE; (submitted: April 19, 2012)	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
Change History	Complete list of historical versions of study NCT01582880 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: June 28, 2017)	Number of Occurrences of Vitritis (Sterile or Infectious) Ulcers [ Time Frame: post op week 52 ]Number of occurrence of vitritis (sterile or infectious) ulcers. Incidences of ulcers were collected by way of slit lamp photography from time of surgery to final visit.; Ocular Safety [ Time Frame: measured at day 1, and week 1, 4, 8, 12, 16, 24, 36, 52 ]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 ]Incidence and severity of systemic adverse events during the study (clinical laboratory, adverse events spontaneously reported).
Original Secondary Outcome Measures ICMJE; (submitted: April 19, 2012)	Lack of sterile ulcers via slit lamp [ Time Frame: post op day 1, week 1, 4, 8, 12, 16, 24, 36, 52. ]; Ocular Safety [ Time Frame: measured at day 1, and week 1, 4, 8, 12, 16, 24, 36, 52 ]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 ]Incidence and severity of systemic adverse events during the study (clinical laboratory, adverse events spontaneously reported).
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
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Chemical Injuries; Unspecified Complication of Corneal Transplant; Autoimmune Diseases; Ocular Cicatricial Pemphigoid; Stevens Johnson Syndrome; Lupus Erythematosus, Systemic; Rheumatoid Arthritis; Other Autoimmune Diseases
Intervention ICMJE	Drug: Riboflavin; Used to treat donor cornea before implantation; Other Name: Riboflavin (vitamin B2) 0.1% solution
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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: June 28, 2017)	1
Original Estimated Enrollment ICMJE; (submitted: April 19, 2012)	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: 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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
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	Plan to Share IPD: No
Responsible Party	Joseph B. Ciolino, MD, Massachusetts Eye and Ear Infirmary
Study Sponsor ICMJE	Joseph B. Ciolino, MD
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Joseph Ciolino, MD Massachusetts Eye and Ear Infirmary
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