Trial · NCT01537393
Cornea Preservation Time Study
NCT01537393, Phase 4, Completed, Case Western Reserve University; results first posted 2018-04-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Cornea Preservation Time Study. Trials, record NCT01537393. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01537393
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cornea Preservation Time Study
- NCT number
- NCT01537393
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 1,174 participants, actual
- Lead sponsor
- Case Western Reserve University
- Conditions
- Cornea Preservation Time, Endothelial Keratoplasty, Transplant Success, Endothelial Cell Density
- Interventions
- Cornea tissue transplant, Cornea tissue transplant
- First posted
- 2012-02-23
- Last updated
- 2018-04-23
- Results first posted
- 2018-04-23
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Eyes With Corneal Graft Failure Within 3 Years of Surgery | Study eye will be assessed for this outcome for 3 years following surgery | 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. |
| Primary | Endothelial Cell Density (ECD) | 3 years from surgery | Endothelial cell density at 3 years from surgery, conditional on graft survival at 3 years from surgery. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Eyes With Corneal Graft Failure Within 3 Years of Surgery | Study eye will be assessed for this outcome for 3 years following surgery | Analyzed number of eyes in each group (Overall 1090 unique participants) | Eyes | COUNT_OF_UNITS |
| PRIMARY | Endothelial Cell Density (ECD) | 3 years from surgery | Eyes with graft success and a gradable image at 3 year (945 eyes of 769 unique participants) | Cells per square millimeter | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Eyes With Corneal Graft Failure Within 3 Years of Surgery | Preservation Time Group 1 | 30 | Eyes | ||
| Number of Eyes With Corneal Graft Failure Within 3 Years of Surgery | Preservation Time Group 2 | 49 | Eyes | ||
| Endothelial Cell Density (ECD) | Preservation Time Group 1 | 1722 | Standard Deviation 626 | Cells per square millimeter | |
| Endothelial Cell Density (ECD) | Preservation Time Group 2 | 1642 | Standard Deviation 631 | Cells per square millimeter |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 0-7d Preservation Time (PT) Group | 707 | 707 |
| Overall Study | STARTED | 8-14d Preservation Time (PT) Group | 698 | 699 |
| Overall Study | COMPLETED | 0-7d Preservation Time (PT) Group | 553 | 553 |
| Overall Study | COMPLETED | 8-14d Preservation Time (PT) Group | 507 | 508 |
| Overall Study | NOT COMPLETED | 0-7d Preservation Time (PT) Group | 154 | 154 |
| Overall Study | NOT COMPLETED | 8-14d Preservation Time (PT) Group | 191 | 191 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Endophthalmitis | Eye disorders | 0-7d Preservation Time Group | 1 | 675 | |
| serious | Endophthalmitis | Eye disorders | 8-14d Preservation Time Group | 0 | 654 | |
| serious | Microbial keratitis | Eye disorders | 0-7d Preservation Time Group | 0 | 675 | |
| serious | Microbial keratitis | Eye disorders | 8-14d Preservation Time Group | 2 | 654 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 0-7d Preservation Time Group | 20 | 675 |
| Total, all-cause mortality | 8-14d Preservation Time Group | 32 | 654 |
| Total, other adverse events | 0-7d Preservation Time Group | 0 | 675 |
| Total, other adverse events | 8-14d Preservation Time Group | 0 | 654 |
| Total, serious adverse events | 0-7d Preservation Time Group | 1 | 675 |
| Total, serious adverse events | 8-14d Preservation Time Group | 2 | 654 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants2
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| U10EY020797 | Effect of Corneal Preservation Time on Long-Term Graft Success (CPTS) | AYALA, ALLISON RENEE | JAEB CENTER FOR HEALTH RESEARCH, INC. | NATIONAL EYE INSTITUTE | 2011 to 2016 | NIH RePORTER |
| U10EY020798 | Effect of Corneal Preservation Time on Long-Term Graft Success (CPTS) | LASS, JONATHAN H | CASE WESTERN RESERVE UNIVERSITY | NATIONAL EYE INSTITUTE | 2011 to 2015 | NIH RePORTER |
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| 0-7d Preservation Time Group vs 8-14d Preservation Time Group: deaths from any cause | Trial comparisons |
| 0-7d Preservation Time Group vs 8-14d Preservation Time Group: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01537393
GET https://conductscience.org/api/trials/v1/NCT01537393/registered