Trial Outcomes & Findings for Cornea Preservation Time Study (NCT NCT01537393)
NCT ID: NCT01537393
Last Updated: 2018-04-23
Results Overview
Graft failure, defined as the occurrence of one of the following within 3 years of surgery: * Regrafting of the study eye for any reason * Cornea which remains cloudy without clearing, according to the following: 1. cloudy cornea on the first postoperative day which does not clear within 8 weeks OR 2. cloudy cornea which was initially clear postoperatively but becomes and remains cloudy for 3 months without clearing.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
1174 participants
Primary outcome timeframe
Study eye will be assessed for this outcome for 3 years following surgery
Results posted on
2018-04-23
Participant Flow
Randomization was at eye level. When both eyes of a participant were included, the eye undergoing surgery 1st was assigned randomly to a PT group and the 2nd eye to the other group. 2 eyes had their assigned donor corneas inadvertently switched, and resulted in 1 of these participants receiving both study eyes from 8-14d group.
Unit of analysis: eyes
Participant milestones
| Measure |
0-7d Preservation Time (PT) Group
Subjects in this arm will receive cornea tissue preserved for up to 7 days prior to transplant.
Cornea tissue transplant: Cornea tissue preserved either 7 or less days or 8 to 14 days.
|
8-14d Preservation Time (PT) Group
Subjects in this arm will receive cornea tissue preserved for 8 to 14 days prior to transplant.
Cornea tissue transplant: Cornea tissue preserved either 7 or less days or 8 to 14 days.
|
|---|---|---|
|
Overall Study
STARTED
|
707 707
|
698 699
|
|
Overall Study
COMPLETED
|
553 553
|
507 508
|
|
Overall Study
NOT COMPLETED
|
154 154
|
191 191
|
Reasons for withdrawal
| Measure |
0-7d Preservation Time (PT) Group
Subjects in this arm will receive cornea tissue preserved for up to 7 days prior to transplant.
Cornea tissue transplant: Cornea tissue preserved either 7 or less days or 8 to 14 days.
|
8-14d Preservation Time (PT) Group
Subjects in this arm will receive cornea tissue preserved for 8 to 14 days prior to transplant.
Cornea tissue transplant: Cornea tissue preserved either 7 or less days or 8 to 14 days.
|
|---|---|---|
|
Overall Study
Exclude prior to study
|
32
|
44
|
|
Overall Study
Death
|
20
|
32
|
|
Overall Study
Withdrawal by Subject
|
18
|
17
|
|
Overall Study
Lost to Follow-up
|
53
|
48
|
|
Overall Study
Failure - Regrafted
|
28
|
43
|
|
Overall Study
Failure - Not regrafted
|
2
|
6
|
|
Overall Study
Censored (severe event unrelated to PT)
|
1
|
1
|
Baseline Characteristics
Cornea Preservation Time Study
Baseline characteristics by cohort
| Measure |
Preservation Time Group 1
n=675 eyes
Subjects in this arm will receive cornea tissue preserved for up to 7 days prior to transplant.
Cornea tissue transplant: Cornea tissue preserved either 7 or less days or 8 to 14 days.
|
Preservation Time Group 2
n=655 eyes
Subjects in this arm will receive cornea tissue preserved for 8 to 14 days prior to transplant.
Cornea tissue transplant: Cornea tissue preserved either 7 or less days or 8 to 14 days.
|
Total
n=1330 eyes
Total of all reporting groups
|
|---|---|---|---|
|
Corneal Dystrophy other than FECD (Fuchs endothelial corneal dystrophy))
No
|
630 eyes
n=32 eyes
|
623 eyes
n=16 eyes
|
1253 eyes
n=48 eyes
|
|
Corneal Dystrophy other than FECD (Fuchs endothelial corneal dystrophy))
Keratoconus
|
1 eyes
n=32 eyes
|
0 eyes
n=16 eyes
|
1 eyes
n=48 eyes
|
|
Age, Continuous
|
70 years
n=32 eyes
|
70 years
n=16 eyes
|
70 years
n=48 eyes
|
|
Sex: Female, Male
Female
|
409 eyes
n=32 eyes
|
392 eyes
n=16 eyes
|
801 eyes
n=48 eyes
|
|
Sex: Female, Male
Male
|
266 eyes
n=32 eyes
|
263 eyes
n=16 eyes
|
529 eyes
n=48 eyes
|
|
Race/Ethnicity, Customized
White
|
613 eyes
n=32 eyes
|
594 eyes
n=16 eyes
|
1207 eyes
n=48 eyes
|
|
Race/Ethnicity, Customized
African American
|
26 eyes
n=32 eyes
|
21 eyes
n=16 eyes
|
47 eyes
n=48 eyes
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
19 eyes
n=32 eyes
|
25 eyes
n=16 eyes
|
44 eyes
n=48 eyes
|
|
Race/Ethnicity, Customized
Asian
|
7 eyes
n=32 eyes
|
5 eyes
n=16 eyes
|
12 eyes
n=48 eyes
|
|
Race/Ethnicity, Customized
American India or Alaskan Native
|
1 eyes
n=32 eyes
|
2 eyes
n=16 eyes
|
3 eyes
n=48 eyes
|
|
Race/Ethnicity, Customized
More than 1 race
|
6 eyes
n=32 eyes
|
3 eyes
n=16 eyes
|
9 eyes
n=48 eyes
|
|
Race/Ethnicity, Customized
Unknown or not reported
|
3 eyes
n=32 eyes
|
5 eyes
n=16 eyes
|
8 eyes
n=48 eyes
|
|
History of Diabetes
|
116 eyes
n=32 eyes
|
126 eyes
n=16 eyes
|
242 eyes
n=48 eyes
|
|
Current cigarette smoker
|
45 eyes
n=32 eyes
|
45 eyes
n=16 eyes
|
90 eyes
n=48 eyes
|
|
Received any immunizations or vaccinations in last 3 mo
|
92 eyes
n=32 eyes
|
81 eyes
n=16 eyes
|
173 eyes
n=48 eyes
|
|
Prior glaucoma surgery
|
18 eyes
n=32 eyes
|
13 eyes
n=16 eyes
|
31 eyes
n=48 eyes
|
|
Glaucoma medication currently being used
|
45 eyes
n=32 eyes
|
54 eyes
n=16 eyes
|
99 eyes
n=48 eyes
|
|
Diagnosis
Pseudophakic corneal edema without FECD
|
44 eyes
n=32 eyes
|
29 eyes
n=16 eyes
|
73 eyes
n=48 eyes
|
|
Diagnosis
Aphakic corneal edema without FECD
|
0 eyes
n=32 eyes
|
2 eyes
n=16 eyes
|
2 eyes
n=48 eyes
|
|
Diagnosis
Fuchs endothelial corneal dystrophy (FECD)
|
631 eyes
n=32 eyes
|
624 eyes
n=16 eyes
|
1255 eyes
n=48 eyes
|
|
Corneal Dystrophy other than FECD (Fuchs endothelial corneal dystrophy))
EBMD (epithelial basement membrane dystrophy)
|
38 eyes
n=32 eyes
|
29 eyes
n=16 eyes
|
67 eyes
n=48 eyes
|
|
Corneal Dystrophy other than FECD (Fuchs endothelial corneal dystrophy))
Other
|
6 eyes
n=32 eyes
|
3 eyes
n=16 eyes
|
9 eyes
n=48 eyes
|
|
Stromal corneal vessels present (but not visually significant)
|
4 eyes
n=32 eyes
|
1 eyes
n=16 eyes
|
5 eyes
n=48 eyes
|
|
Central subepithelial/stromal scarring present (not affect postoperative stromal clarity assessment)
|
37 eyes
n=32 eyes
|
48 eyes
n=16 eyes
|
85 eyes
n=48 eyes
|
|
Peripheral anterior synechiae present (nongonioscopic)
|
4 eyes
n=32 eyes
|
2 eyes
n=16 eyes
|
6 eyes
n=48 eyes
|
|
Preoperative lens status
Phakic
|
341 eyes
n=32 eyes
|
351 eyes
n=16 eyes
|
692 eyes
n=48 eyes
|
|
Preoperative lens status
Aphakic
|
0 eyes
n=32 eyes
|
2 eyes
n=16 eyes
|
2 eyes
n=48 eyes
|
|
Preoperative lens status
Pseudophakic posterior chamber intraocular lens
|
334 eyes
n=32 eyes
|
302 eyes
n=16 eyes
|
636 eyes
n=48 eyes
|
|
Postoperative lens status
Phakic
|
4 eyes
n=32 eyes
|
6 eyes
n=16 eyes
|
10 eyes
n=48 eyes
|
|
Postoperative lens status
Pseudophakic posterior chamber intraocular lens
|
671 eyes
n=32 eyes
|
649 eyes
n=16 eyes
|
1320 eyes
n=48 eyes
|
|
Intraocular pressure (IOP)
|
15 mm Hg
n=32 eyes
|
15 mm Hg
n=16 eyes
|
15 mm Hg
n=48 eyes
|
PRIMARY outcome
Timeframe: Study eye will be assessed for this outcome for 3 years following surgeryPopulation: Analyzed number of eyes in each group (Overall 1090 unique participants)
Graft failure, defined as the occurrence of one of the following within 3 years of surgery: * Regrafting of the study eye for any reason * Cornea which remains cloudy without clearing, according to the following: 1. cloudy cornea on the first postoperative day which does not clear within 8 weeks OR 2. cloudy cornea which was initially clear postoperatively but becomes and remains cloudy for 3 months without clearing.
Outcome measures
| Measure |
Preservation Time Group 1
n=675 Eyes
Subjects in this arm will receive cornea tissue preserved for up to 7 days prior to transplant.
Cornea tissue transplant: Cornea tissue preserved either 7 or less days or 8 to 14 days.
|
Preservation Time Group 2
n=655 Eyes
Subjects in this arm will receive cornea tissue preserved for 8 to 14 days prior to transplant.
Cornea tissue transplant: Cornea tissue preserved either 7 or less days or 8 to 14 days.
|
|---|---|---|
|
Number of Eyes With Corneal Graft Failure Within 3 Years of Surgery
|
30 Eyes
|
49 Eyes
|
PRIMARY outcome
Timeframe: 3 years from surgeryPopulation: Eyes with graft success and a gradable image at 3 year (945 eyes of 769 unique participants)
Endothelial cell density at 3 years from surgery, conditional on graft survival at 3 years from surgery.
Outcome measures
| Measure |
Preservation Time Group 1
n=485 eyes
Subjects in this arm will receive cornea tissue preserved for up to 7 days prior to transplant.
Cornea tissue transplant: Cornea tissue preserved either 7 or less days or 8 to 14 days.
|
Preservation Time Group 2
n=460 eyes
Subjects in this arm will receive cornea tissue preserved for 8 to 14 days prior to transplant.
Cornea tissue transplant: Cornea tissue preserved either 7 or less days or 8 to 14 days.
|
|---|---|---|
|
Endothelial Cell Density (ECD)
|
1722 Cells per square millimeter
Standard Deviation 626
|
1642 Cells per square millimeter
Standard Deviation 631
|
Adverse Events
0-7d Preservation Time Group
Serious events: 1 serious events
Other events: 0 other events
Deaths: 20 deaths
8-14d Preservation Time Group
Serious events: 2 serious events
Other events: 0 other events
Deaths: 32 deaths
Serious adverse events
| Measure |
0-7d Preservation Time Group
n=675 participants at risk
Subjects in this arm will receive cornea tissue preserved for up to 7 days prior to transplant.
Cornea tissue transplant: Cornea tissue preserved either 7 or less days or 8 to 14 days.
|
8-14d Preservation Time Group
n=654 participants at risk
Subjects in this arm will receive cornea tissue preserved for 8 to 14 days prior to transplant.
Cornea tissue transplant: Cornea tissue preserved either 7 or less days or 8 to 14 days.
|
|---|---|---|
|
Eye disorders
Endophthalmitis
|
0.15%
1/675 • Through study completion, up to 5 years
Adverse event was collected at eye level
|
0.00%
0/654 • Through study completion, up to 5 years
Adverse event was collected at eye level
|
|
Eye disorders
Microbial keratitis
|
0.00%
0/675 • Through study completion, up to 5 years
Adverse event was collected at eye level
|
0.31%
2/654 • Through study completion, up to 5 years
Adverse event was collected at eye level
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place