Trial Outcomes & Findings for Study of Eye Bank Pre-cut Donor Grafts for Endothelial Keratoplasty (NCT NCT00624221)
NCT ID: NCT00624221
Last Updated: 2016-04-27
Results Overview
Endothelial cell density was measured by specular or confocal microscopy. Percent cell loss was calculated by subtracting the graft endothelial cell density measured at 6 months from the baseline donor endothelial cell density and dividing by the baseline donor endothelial cell density then multiplying by 100.
COMPLETED
NA
40 participants
6 months after grafting
2016-04-27
Participant Flow
Participant milestones
| Measure |
Eye Bank Pre-cut Grafts
An Eye bank pre-cut the donor grafts used for the corneal transplant procedures.
|
Surgeon Dissected Grafts
The surgeon dissected the donor grafts used for the transplant procedures.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Eye Bank Pre-cut Donor Grafts for Endothelial Keratoplasty
Baseline characteristics by cohort
| Measure |
Eye Bank Pre-cut Grafts
n=20 Participants
An Eye bank pre-cut the donor grafts used for the corneal transplant procedures.
|
Surgeon Dissected Grafts
n=20 Participants
The surgeon dissected the donor grafts used for the transplant procedures.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70 years
STANDARD_DEVIATION 12 • n=93 Participants
|
72 years
STANDARD_DEVIATION 13 • n=4 Participants
|
71 years
STANDARD_DEVIATION 12 • n=27 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=93 Participants
|
20 participants
n=4 Participants
|
40 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 6 months after graftingEndothelial cell density was measured by specular or confocal microscopy. Percent cell loss was calculated by subtracting the graft endothelial cell density measured at 6 months from the baseline donor endothelial cell density and dividing by the baseline donor endothelial cell density then multiplying by 100.
Outcome measures
| Measure |
Eye Bank Pre-cut Grafts
n=20 Participants
An Eye bank pre-cut the donor grafts used for the corneal transplant procedures.
|
Surgeon Dissected Grafts
n=20 Participants
The surgeon dissected the donor grafts used for the transplant procedures.
|
|---|---|---|
|
Endothelial Cell Loss
|
28 percentage of endothelial cell loss
Standard Deviation 20
|
36 percentage of endothelial cell loss
Standard Deviation 18
|
SECONDARY outcome
Timeframe: 6 months and 1 year after graftingOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 day to 1 month after graftingOutcome measures
Outcome data not reported
Adverse Events
Eye Bank Pre-cut Grafts
Surgeon Dissected Grafts
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Eye Bank Pre-cut Grafts
n=20 participants at risk
An Eye bank pre-cut the donor grafts used for the corneal transplant procedures.
|
Surgeon Dissected Grafts
n=20 participants at risk
The surgeon dissected the donor grafts used for the transplant procedures.
|
|---|---|---|
|
Eye disorders
graft dislocation and reattachment
|
10.0%
2/20 • Number of events 2 • 1 year
|
10.0%
2/20 • Number of events 2 • 1 year
|
|
Eye disorders
graft rejection episode
|
10.0%
2/20 • Number of events 2 • 1 year
|
0.00%
0/20 • 1 year
|
Additional Information
Marianne O. Price, PhD
Cornea Research Foundation of America
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place