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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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):

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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Riboflavin: Used to treat donor cornea before implantation


Participant Flow:   Overall Study
    Riboflavin Cross-linked Donor Cornea
STARTED   1 
COMPLETED   1 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Riboflavin: Used to treat donor cornea before implantation


Baseline Measures
   Riboflavin Cross-linked Donor Cornea 
Overall Participants Analyzed 
[Units: Participants]
 1 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 52 [1] 
[1] Standard Deviation is not applicable for a single participant
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      0   0.0% 
Male      1 100.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      0   0.0% 
Not Hispanic or Latino      1 100.0% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of 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 
[Units: Participants]
 
United States   1 
corneal thickness measured at 1mm one day post op [1] 
[Units: µm]
 730 
[1] "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] 
[Units: µm]
 940 
[1] "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.


  Outcome Measures

1.  Primary:   Changes in Corneal Thickness at 1 Millimeter   [ Time Frame: measured at week 4, 6, 26, 32, 52 ]

2.  Primary:   Changes in Corneal Thickness at 2 Millimeter   [ Time Frame: measured at week 4, 6, 26, 32, 52 ]

3.  Secondary:   Number of Occurrences of Vitritis (Sterile or Infectious) Ulcers   [ Time Frame: post op week 52 ]

4.  Secondary:   Ocular Safety   [ Time Frame: measured at day 1, and week 1, 4, 8, 12, 16, 24, 36, 52 ]

5.  Secondary:   Systemic Safety   [ Time Frame: measured at day 1, and week 1, 4, 8, 12, 16, 24, 36, 52 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: joseph_ciolino@meei.harvard.edu



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