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

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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

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.
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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.

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 ]

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
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