Cornea Preservation TimePhase 4CPTSNCT01537393
Cornea Preservation Time Study
A Phase 4 study testing Cornea tissue transplant in people with Cornea Preservation Time and Endothelial Keratoplasty, run by Case Western Reserve University at 40 sites in United States.
Trial summary
The purpose of this study is to determine if the 3-year graft failure rate following endothelial keratoplasty performed with donor corneas with a preservation time of 8 to 14 days is non-inferior to the failure rate when donor corneas with a preservation time of 7 or fewer days are used. Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Cornea Preservation Time, Endothelial Keratoplasty, Transplant Success
- What is being tested?
- Cornea tissue transplant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,174 participants
- Where
- 40 sitesUnited States
- Study dates
- 16 Apr 2012to 30 Jun 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study Participant Eligibility Criteria
- Study Participant Inclusion Criteria
- Age range 30-<91 years with minimum life expectancy of at least 3 years.
- Willingness to return for follow-up study visits at 1 day, 1 week, 1 month, 6 months, 1 year, 2 years and 3 years.
- Fluent in English or Spanish.
- Study Participant Exclusion Criteria 1) Decisionally and/or cognitively impaired
Study Eye Eligibility Criteria
- Study Eye Inclusion Criteria
- Endothelial keratoplasty (EK) is scheduled between 10 and 60 days after enrollment
- The 10-day requirement relates to the need to be able to randomly assign the eye to either intervention group.
- The 60-day requirement relates to the need to have current eligibility and enrollment data at the time of surgery. If surgery is postponed to >60 days after the initial enrollment visit, a new Baseline Visit and eligibility assessment will have to be performed.
- Presence of a condition related to endothelial dysfunction which will be treated by EK.
- Eligible indications for EK include:
- Presence of Fuchs endothelial corneal dystrophy (FECD) meeting at least one of the following:
- Phakic FECD
- Phakic FECD with cataract
- Triple procedure including EK for FECD, cataract extraction and posterior chamber intraocular lens implantation (IOL) is allowed
- Aphakic FECD
- Pseudophakic FECD with posterior capsule supported, suture-fixated, or sulcus-supported posterior chamber IOL
- Aphakic or pseudophakic corneal edema with posterior capsule supported, suture-fixated, or sulcus-supported posterior chamber IOL without FECD
- Study Eye Exclusion Criteria
- Prior EK
- Indication for surgery that is not suitable for EK (e.g, keratoconus, stromal dystrophies and scars)
- Presence of a condition that has a very high probability for failure (e.g., failed EK or Penetrating Keratoplasty (PKP), heavily vascularized cornea, uncontrolled uveitis)
- Other primary endothelial dysfunction conditions including posterior polymorphous corneal dystrophy and congenital hereditary corneal dystrophy
- Anterior chamber IOL in study eye prior to or anticipated during EK
- Planned intraocular lens exchange of an anterior chamber IOL with a posterior chamber IOL in study eye at time of study EK
- Pre-operative central sub-epithelial or stromal scarring that the investigator believes is visually significant and could impact post-operative stromal clarity assessment
- Stromal vascularization that is visually significant (by investigator's judgment)
- Presence of anterior synechiae (iris to cornea)
- Peripheral anterior synechiae (iris to angle) in the angle greater than a total of three clock hours
- Hypotony (Intraocular pressure <10 mm Hg)
- Uncontrolled (defined as intraocular pressure > 25mm Hg) glaucoma with or without prior filtering surgery or shunt or mini-shunt placement.
- A shunt or mini-shunt is any device implanted to lower intraocular pressure through an external route (e.g Ahmed) or internal route (e.g. Glaukos) that is present in the anterior chamber angle or extends into the anterior chamber.
- Controlled glaucoma with prior shunt or mini-shunt placement for glaucoma
- Note: FECD or pseudophakic/aphakic corneal edema with posterior chamber IOL that also have undergone filtering surgery (without shunt or mini-shunt) in which glaucoma is currently considered under control will be eligible
- Fellow eye visual acuity < 20/200 that is not correctable with EK
Eligibility Criteria for Second Study Eye
- Study participant has already enrolled one eye
- The second eye meets all study eye inclusion and exclusion criteria (2.2.2 and 2.2.3)
- EK surgery in second eye is not planned within 6 weeks of EK on first study eye
Trial locations and contacts
40 sites in 1 country.
40 sites in 1 country
United States40 sites
University of Michigan/Kellogg Eye Center
Ann Arbor, Michigan, 48105
Woolfson Eye Institute
Atlanta, Georgia, 30328
Eye Consultants of Atlanta
Atlanta, Georgia, 30339
Ophthalmic Partners of PA
Bala-Cynwyd, Pennsylvania, 19053
Mid-Atlantic Cornea Consultants
Baltimore, Maryland, 21204
Johns Hopkins/Wilmer Eye Institute
Baltimore, Maryland, 21205
Keck Medical Center
Beverly Hills, California, 90211
Minnesota Eye Consultants
Bloomington, Minnesota, 55431
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114
University of Illinois Eye and Eye
Chicago, Illinois, 60612
Cincinnati Eye Institute
Cincinnati, Ohio, 45242
University Hospitals Case Medical Center Eye Institute
Cleveland, Ohio, 44106
Ohio State Medical Center
Columbus, Ohio, 43212
Cornea Associates of Texas
Dallas, Texas, 75231
NorthShore University Health System
Glenview, Illinois, 60026
Verdier Eye Center
Grand Rapids, Michigan, 49546
Central Pennsylvania Eye Institute
Hershey, Pennsylvania, 17033
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Northeast Ohio Eye Surgeons
Kent, Ohio, 44240
Sadeer Hannush, MD
Langhorne, Pennsylvania, 19047
University of Kentucky Ophthalmology
Lexington, Kentucky, 40503
Jules Stein Eye Institute
Los Angeles, California, 90095
Dean Medical Center
Madison, Wisconsin, 53715
Medical Eye Center
Medford, Oregon, 97504
Bascom Palmer Eye Institute
Miami, Florida, 33136
New York Eye and Ear Infirmary
New York, New York, 10003
Eye Consultants of Maryland
Owings Mills, Maryland, 21117
Corneal Associates, PC, Wills Eye Institute
Philadelphia, Pennsylvania, 19107
Devers Eye Institute
Portland, Oregon, 97210
Mayo Clinic
Rochester, Minnesota, 55905
University of Utah, Moran Eye Center
Salt Lake City, Utah, 84132
Focal Point Vision
San Antonio, Texas, 78229
Eye Care of San Diego
San Diego, California, 92103
University of California, San Francisco
San Francisco, California, 94110
Center for Sight
Sarasota, Florida, 34239
Eye Associates Northwest
Seattle, Washington, 98104
Cornea Consultants of Albany
Slingerlands, New York, 12159
Michigan Cornea Consultants
Southfield, Michigan, 48034
Mercy Medical Research Institute
Springfield, Missouri, 65804
Ophthalmology Associates
St Louis, Missouri, 63131
About this study
Official title: Effect of Corneal Preservation Time on Long-Term Graft Success
The purpose of this study is to determine if the 3-year graft failure rate following endothelial keratoplasty performed with donor corneas with a preservation time of 8 to 14 days is non-inferior to the failure rate when donor corneas with a preservation time of 7 or fewer days are used.
Read the detailed description
When the donor cornea is removed from the person who died, it is prepared for transplantation by an eye bank. The donor cornea is placed into a liquid that helps preserve the cornea until it is transplanted. The Food and Drug Administration (FDA) has approved storage of the cornea in this liquid for up to 14 days before the transplant. The purpose of this study is to see if the length of time the donor cornea is kept in the preservation liquid before the transplant affects the likelihood of the transplant being successful. We will follow participants for 3 years after transplant to see if there are any differences in transplant success or in the number of transplanted endothelial cells (the layer of cells that line the undersurface of the cornea) on the corneas that were preserved for 7 days or less compared to those preserved between 8 and 14 days. We have no reason to believe that there is any greater risk for transplant failure with either preservation time group.
- Conditions
- Cornea Preservation Time, Endothelial Keratoplasty, Transplant Success, Endothelial Cell Density
- Being tested
- Cornea tissue transplant
- Keywords
- cornea, transplant, preservation, endothelial keratoplasty
- Medical subject headings
- Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cornea tissue transplantBiological
Cornea tissue preserved 0 to 7 days
Cornea tissue transplantBiological
Cornea tissue preserved 8 to 14 days.
| Study group | Role | What they receive |
|---|---|---|
| 0-7d Preservation Time Group | Other | Subjects in this arm will receive cornea tissue transplant with cornea tissue preserved for 0 to 7 days prior to transplant. Receives: Biological: Cornea tissue transplant |
| 8-14d Preservation Time Group | Other | Subjects in this arm will receive cornea tissue transplant with cornea tissue preserved for 8 to 14 days prior to transplant. Receives: Biological: Cornea tissue transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Eyes With Corneal Graft Failure Within 3 Years of 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:
- cloudy cornea on the first postoperative day which does not clear within 8 weeks OR
- cloudy cornea which was initially clear postoperatively but becomes and remains cloudy for 3 months without clearing.
Measured: Study eye will be assessed for this outcome for 3 years following surgery
Endothelial Cell Density (ECD)
Endothelial cell density at 3 years from surgery, conditional on graft survival at 3 years from surgery.
Measured: 3 years from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2012 (estimated)
- Study start16 Apr 2012
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cornea Preservation TimeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI), Jaeb Center for Health Research
- Responsible party
- Principal investigator, Jonathan Lass, MD, Case Western Reserve University
- Investigators
- Jonathan Lass, MD, Study chair, Case Western Reserve UniversityAllison Ayala, MS, Principal investigator, Jaeb Center for Health Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01537393
- Sponsor's protocol ID
- CPTS
- Other IDs
- 1U10EY020798-01A1, 1U10EY020797-01A1
- Acronym
- CPTS
- Status last verified
- Apr 2018
- First submitted
- 15 Feb 2012
- Last updated
- 23 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Rosenwasser GO, Szczotka-Flynn LB, Ayala AR, Liang W, Aldave AJ, Dunn SP, McCall T, Navarro LC, Pramanik S, Ross KW, Stulting RD, Terry MA, Tu EY, Verdier DD, Kollman C, Gal RL, Beck RW, Lass JH; Cornea Preservation Time Study Group. Effect of Cornea Preservation Time on Success of Descemet Stripping Automated Endothelial Keratoplasty: A Randomized Clinical Trial. JAMA Ophthalmol. 2017 Dec 1;135(12):1401-1409. doi: 10.1001/jamaophthalmol.2017.4989.
PubMed 29127431Lass JH, Benetz BA, Verdier DD, Szczotka-Flynn LB, Ayala AR, Liang W, Aldave AJ, Dunn SP, McCall T, Mian SI, Navarro LC, Patel SV, Pramanik S, Rosenwasser GO, Ross KW, Terry MA, Kollman C, Gal RL, Beck RW; Cornea Preservation Time Study Group. Corneal Endothelial Cell Loss 3 Years After Successful Descemet Stripping Automated Endothelial Keratoplasty in the Cornea Preservation Time Study: A Randomized Clinical Trial. JAMA Ophthalmol. 2017 Dec 1;135(12):1394-1400. doi: 10.1001/jamaophthalmol.2017.4970.
PubMed 29127432Lass JH, Bailey RJ, Szczotka-Flynn LB, Benetz BA, Soper M, Titus MS, Kollman C, Beck RW; Cornea Preservation Time Study Group. Comparison of Graft Outcomes Reusing Original Intermediate-Term Cold Storage Solution for Entire Corneal Donor Storage Period With Exchanged Fresh Storage Solution After Donor Preparation in the Cornea Preservation Time Study. Cornea. 2022 Dec 1;41(12):1539-1544. doi: 10.1097/ICO.0000000000003108. Epub 2022 Sep 9.
PubMed 36036663Lass JH, Szczotka-Flynn LB, Ayala AR, Benetz BA, Gal RL, Aldave AJ, Corrigan MM, Dunn SP, McCall TL, Pramanik S, Rosenwasser GO, Ross KW, Terry MA, Verdier DD; Writing Committee for the Cornea Preservation Time Study Group. Cornea preservation time study: methods and potential impact on the cornea donor pool in the United States. Cornea. 2015 Jun;34(6):601-8. doi: 10.1097/ICO.0000000000000417.
PubMed 25850706
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Corneal Preservation Time on Long-Term Graft Success
- ClinicalTrials.gov ID
- NCT01537393
- Acronym / sponsor ID
- CPTS / CPTS
- Conditions
- Cornea Preservation Time, Endothelial Keratoplasty, Transplant Success, Endothelial Cell Density
- Keywords
- cornea, transplant, preservation, endothelial keratoplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,174 participants (actual)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI), Jaeb Center for Health Research
- Study start
- 16 Apr 2012 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 23 Feb 2012 (estimated)
- Results
- Posted 23 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if the 3-year graft failure rate following endothelial keratoplasty performed with donor corneas with a preservation time of 8 to 14 days is non-inferior to the failure rate when donor corneas with a preservation time of 7 or fewer days are used.
Detailed description
When the donor cornea is removed from the person who died, it is prepared for transplantation by an eye bank. The donor cornea is placed into a liquid that helps preserve the cornea until it is transplanted. The Food and Drug Administration (FDA) has approved storage of the cornea in this liquid for up to 14 days before the transplant. The purpose of this study is to see if the length of time the donor cornea is kept in the preservation liquid before the transplant affects the likelihood of the transplant being successful. We will follow participants for 3 years after transplant to see if there are any differences in transplant success or in the number of transplanted endothelial cells (the layer of cells that line the undersurface of the cornea) on the corneas that were preserved for 7 days or less compared to those preserved between 8 and 14 days. We have no reason to believe that there is any greater risk for transplant failure with either preservation time group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0-7d Preservation Time Group | Other | Biological: Cornea tissue transplantSubjects in this arm will receive cornea tissue transplant with cornea tissue preserved for 0 to 7 days prior to transplant. |
| 8-14d Preservation Time Group | Other | Biological: Cornea tissue transplantSubjects in this arm will receive cornea tissue transplant with cornea tissue preserved for 8 to 14 days prior to transplant. |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cornea tissue transplantCornea tissue preserved 0 to 7 days | Biological | 0-7d Preservation Time Group |
| Cornea tissue transplantCornea tissue preserved 8 to 14 days. | Biological | 8-14d Preservation Time Group |
Primary outcome
Number of Eyes With Corneal Graft Failure Within 3 Years of Surgery
Time frame: 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.
Endothelial Cell Density (ECD)
Time frame: 3 years from surgery
Endothelial cell density at 3 years from surgery, conditional on graft survival at 3 years from surgery.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 29127431Rosenwasser GO, Szczotka-Flynn LB, Ayala AR, Liang W, Aldave AJ, Dunn SP, McCall T, Navarro LC, Pramanik S, Ross KW, Stulting RD, Terry MA, Tu EY, Verdier DD, Kollman C, Gal RL, Beck RW, Lass JH; Cornea Preservation Time Study Group. Effect of Cornea Preservation Time on Success of Descemet Stripping Automated Endothelial Keratoplasty: A Randomized Clinical Trial. JAMA Ophthalmol. 2017 Dec 1;135(12):1401-1409. doi: 10.1001/jamaophthalmol.2017.4989.
- Results publication: PubMed 29127432Lass JH, Benetz BA, Verdier DD, Szczotka-Flynn LB, Ayala AR, Liang W, Aldave AJ, Dunn SP, McCall T, Mian SI, Navarro LC, Patel SV, Pramanik S, Rosenwasser GO, Ross KW, Terry MA, Kollman C, Gal RL, Beck RW; Cornea Preservation Time Study Group. Corneal Endothelial Cell Loss 3 Years After Successful Descemet Stripping Automated Endothelial Keratoplasty in the Cornea Preservation Time Study: A Randomized Clinical Trial. JAMA Ophthalmol. 2017 Dec 1;135(12):1394-1400. doi: 10.1001/jamaophthalmol.2017.4970.
- Derived from this study: PubMed 36036663Lass JH, Bailey RJ, Szczotka-Flynn LB, Benetz BA, Soper M, Titus MS, Kollman C, Beck RW; Cornea Preservation Time Study Group. Comparison of Graft Outcomes Reusing Original Intermediate-Term Cold Storage Solution for Entire Corneal Donor Storage Period With Exchanged Fresh Storage Solution After Donor Preparation in the Cornea Preservation Time Study. Cornea. 2022 Dec 1;41(12):1539-1544. doi: 10.1097/ICO.0000000000003108. Epub 2022 Sep 9.
- Derived from this study: PubMed 25850706Lass JH, Szczotka-Flynn LB, Ayala AR, Benetz BA, Gal RL, Aldave AJ, Corrigan MM, Dunn SP, McCall TL, Pramanik S, Rosenwasser GO, Ross KW, Terry MA, Verdier DD; Writing Committee for the Cornea Preservation Time Study Group. Cornea preservation time study: methods and potential impact on the cornea donor pool in the United States. Cornea. 2015 Jun;34(6):601-8. doi: 10.1097/ICO.0000000000000417.
- Public websiteLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Lass, MD study chair
Case Western Reserve University
Allison Ayala, MS principal investigator
Jaeb Center for Health Research
40 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cornea tissue transplant in people with Cornea Preservation Time and Endothelial Keratoplasty, run by Case Western Reserve University at 40 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Eyes With Corneal Graft Failure Within 3 Years of Surgery (time frame: Study eye will be assessed for this outcome for 3 years following surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01537393, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2018.