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

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ClinicalTrials.gov Identifier: NCT01582880
Recruitment Status : Completed
First Posted : April 23, 2012
Results First Posted : July 24, 2017
Last Update Posted : September 18, 2017
Sponsor:
Information provided by (Responsible Party):
Joseph B. Ciolino, MD, Massachusetts Eye and Ear Infirmary

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Chemical Injuries
Unspecified Complication of Corneal Transplant
Autoimmune Diseases
Ocular Cicatricial Pemphigoid
Stevens Johnson Syndrome
Lupus Erythematosus, Systemic
Rheumatoid Arthritis
Other Autoimmune Diseases
Intervention Drug: Riboflavin
Enrollment 1
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Riboflavin Cross-linked Donor Cornea
Hide Arm/Group Description

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.

Riboflavin: Used to treat donor cornea before implantation

Period Title: Overall Study
Started 1
Completed 1
Not Completed 0
Arm/Group Title Riboflavin Cross-linked Donor Cornea
Hide Arm/Group Description

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.

Riboflavin: Used to treat donor cornea before implantation

Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1 participants
52 [1]   (NA)
[1]
Standard Deviation is not applicable for a single participant
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
0
   0.0%
Male
1
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
1
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
1
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants
1
corneal thickness measured at 1mm one day post op   [1] 
Measure Type: Number
Unit of measure:  µm
Number Analyzed 1 participants
730
[1]
Measure Description: "corneal thickness measured at 1mm one day post op" is the baseline measurement for this study. This study evaluated cross-linked cornea tissue versus standard of care cornea tissue after transplant procedure. Therefore the measurement at one day post op is the baseline measurement.
corneal thickness measured at 2mm one day post op   [1] 
Measure Type: Number
Unit of measure:  µm
Number Analyzed 1 participants
940
[1]
Measure Description: "corneal thickness measured at 2mm one day post op" is the baseline measurement for this study. This study evaluated cross-linked cornea tissue versus standard of care cornea tissue after transplant procedure. Therefore the measurement at one day post op is the baseline measurement.
1.Primary Outcome
Title Changes in Corneal Thickness at 1 Millimeter
Hide Description 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.
Time Frame measured at week 4, 6, 26, 32, 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
52 year old white male patient
Arm/Group Title Riboflavin Cross-linked Donor Cornea
Hide Arm/Group Description:

The donor cornea used as a carrier for the Boston Keratoprosthesis underwent crosslinking treatment before being trephined and prepared for implantation with the Keratoprosthesis.

Riboflavin: Used to treat donor cornea before implantation

Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: micrometer
week 4 corneal thickness 730
week 6 corneal thickness 760
week 26 corneal thickness 700
week 32 corneal thickness 720
week 52 corneal thickness 680
2.Primary Outcome
Title Changes in Corneal Thickness at 2 Millimeter
Hide Description 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.
Time Frame measured at week 4, 6, 26, 32, 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
52 year old white male patient
Arm/Group Title Riboflavin Cross-linked Donor Cornea
Hide Arm/Group Description:

The donor cornea used as a carrier for the Boston Keratoprosthesis underwent crosslinking treatment before being trephined and prepared for implantation with the Keratoprosthesis.

Riboflavin: Used to treat donor cornea before implantation

Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: micrometer
week 4 corneal thickness 940
week 6 corneal thickness 860
week 26 corneal thickness 820
week 32 corneal thickness 795
week 52 corneal thickness 780
3.Secondary Outcome
Title Number of Occurrences of Vitritis (Sterile or Infectious) Ulcers
Hide Description 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.
Time Frame post op week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
52 year old white male
Arm/Group Title Riboflavin Cross-linked Donor Cornea
Hide Arm/Group Description:

The donor cornea used as a carrier for the Boston Keratoprosthesis underwent crosslinking treatment before being trephined and prepared for implantation with the Keratoprosthesis.

Riboflavin: Used to treat donor cornea before implantation

Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: occurrences
0
4.Secondary Outcome
Title Ocular Safety
Hide Description Incidence and severity of ocular adverse events during the study (ophthalmic examination, adverse events spontaneously reported)
Time Frame measured at day 1, and week 1, 4, 8, 12, 16, 24, 36, 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
52 year old white male
Arm/Group Title Riboflavin Cross-linked Donor Cornea
Hide Arm/Group Description:

The donor cornea used as a carrier for the Boston Keratoprosthesis underwent crosslinking treatment before being trephined and prepared for implantation with the Keratoprosthesis.

Riboflavin: Used to treat donor cornea before implantation

Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: Incidences
0
5.Secondary Outcome
Title Systemic Safety
Hide Description Incidence and severity of systemic adverse events during the study (clinical laboratory, adverse events spontaneously reported).
Time Frame measured at day 1, and week 1, 4, 8, 12, 16, 24, 36, 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
52 year old white male
Arm/Group Title Riboflavin Cross-linked Donor Cornea
Hide Arm/Group Description:

The donor cornea used as a carrier for the Boston Keratoprosthesis underwent crosslinking treatment before being trephined and prepared for implantation with the Keratoprosthesis.

Riboflavin: Used to treat donor cornea before implantation

Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: Incidences
0
Time Frame This study enrolled one study subject. The study subject was followed for Adverse Events from the time of signing the study informed consent form 2/12/2013 to one year post surgery 3/13/2014
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Riboflavin Cross-linked Donor Cornea
Hide Arm/Group Description

The donor cornea used as a carrier for the Boston Keratoprosthesis underwent crosslinking treatment before being trephined and prepared for implantation with the Keratoprosthesis.

Riboflavin: Used to treat donor cornea before implantation

All-Cause Mortality
Riboflavin Cross-linked Donor Cornea
Affected / at Risk (%)
Total   0/1 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Riboflavin Cross-linked Donor Cornea
Affected / at Risk (%)
Total   0/1 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Riboflavin Cross-linked Donor Cornea
Affected / at Risk (%)
Total   0/1 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Joseph Ciolino, MD
Organization: Massachusetts Eye and Ear Infirmary
Phone: 617-573-4437
Responsible Party: Joseph B. Ciolino, MD, Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT01582880     History of Changes
Other Study ID Numbers: 10-03-020
First Submitted: April 10, 2012
First Posted: April 23, 2012
Results First Submitted: March 21, 2017
Results First Posted: July 24, 2017
Last Update Posted: September 18, 2017