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| ID | Type | Description | Link |
|---|---|---|---|
| 1U10EY020798-01A1 | U.S. NIH Grant/Contract | View source | |
| 1U10EY020797-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Eye Institute (NEI) | NIH |
| Jaeb Center for Health Research | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cornea tissue transplant | Biological | Cornea tissue preserved 0 to 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 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. | 3 years from surgery |
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Study Participant Eligibility Criteria
Study Participant Inclusion Criteria
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
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
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.
Controlled glaucoma with prior shunt or mini-shunt placement for glaucoma
Fellow eye visual acuity < 20/200 that is not correctable with EK
Eligibility Criteria for Second Study Eye
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Lass, MD | Case Western Reserve University | Study Chair |
| Allison Ayala, MS | Jaeb Center for Health Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keck Medical Center | Beverly Hills | California | 90211 | United States | ||
| Jules Stein Eye Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29127431 | Result | 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. | |
| 29127432 |
| Label | URL |
|---|---|
| Public website | View source |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 8-14d Preservation Time (PT) Group |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 1, 2015 |
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| Cornea tissue transplant | Biological | Cornea tissue preserved 8 to 14 days. |
|
| Los Angeles |
| California |
| 90095 |
| United States |
| Eye Care of San Diego | San Diego | California | 92103 | United States |
| University of California, San Francisco | San Francisco | California | 94110 | United States |
| Bascom Palmer Eye Institute | Miami | Florida | 33136 | United States |
| Center for Sight | Sarasota | Florida | 34239 | United States |
| Woolfson Eye Institute | Atlanta | Georgia | 30328 | United States |
| Eye Consultants of Atlanta | Atlanta | Georgia | 30339 | United States |
| University of Illinois Eye and Eye | Chicago | Illinois | 60612 | United States |
| NorthShore University Health System | Glenview | Illinois | 60026 | United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| University of Kentucky Ophthalmology | Lexington | Kentucky | 40503 | United States |
| Mid-Atlantic Cornea Consultants | Baltimore | Maryland | 21204 | United States |
| Johns Hopkins/Wilmer Eye Institute | Baltimore | Maryland | 21205 | United States |
| Eye Consultants of Maryland | Owings Mills | Maryland | 21117 | United States |
| Ophthalmic Consultants of Boston | Boston | Massachusetts | 02114 | United States |
| University of Michigan/Kellogg Eye Center | Ann Arbor | Michigan | 48105 | United States |
| Verdier Eye Center | Grand Rapids | Michigan | 49546 | United States |
| Michigan Cornea Consultants | Southfield | Michigan | 48034 | United States |
| Minnesota Eye Consultants | Bloomington | Minnesota | 55431 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Mercy Medical Research Institute | Springfield | Missouri | 65804 | United States |
| Ophthalmology Associates | St Louis | Missouri | 63131 | United States |
| New York Eye and Ear Infirmary | New York | New York | 10003 | United States |
| Cornea Consultants of Albany | Slingerlands | New York | 12159 | United States |
| Cincinnati Eye Institute | Cincinnati | Ohio | 45242 | United States |
| University Hospitals Case Medical Center Eye Institute | Cleveland | Ohio | 44106 | United States |
| Ohio State Medical Center | Columbus | Ohio | 43212 | United States |
| Northeast Ohio Eye Surgeons | Kent | Ohio | 44240 | United States |
| Medical Eye Center | Medford | Oregon | 97504 | United States |
| Devers Eye Institute | Portland | Oregon | 97210 | United States |
| Ophthalmic Partners of PA | Bala-Cynwyd | Pennsylvania | 19053 | United States |
| Central Pennsylvania Eye Institute | Hershey | Pennsylvania | 17033 | United States |
| Sadeer Hannush, MD | Langhorne | Pennsylvania | 19047 | United States |
| Corneal Associates, PC, Wills Eye Institute | Philadelphia | Pennsylvania | 19107 | United States |
| Cornea Associates of Texas | Dallas | Texas | 75231 | United States |
| Focal Point Vision | San Antonio | Texas | 78229 | United States |
| University of Utah, Moran Eye Center | Salt Lake City | Utah | 84132 | United States |
| Eye Associates Northwest | Seattle | Washington | 98104 | United States |
| Dean Medical Center | Madison | Wisconsin | 53715 | United States |
| Lass 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. |
| 36036663 | Derived | Lass 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. |
| 25850706 | Derived | Lass 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. |
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. |
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| COMPLETED | Study eyes with 3-year visit completed |
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| NOT COMPLETED |
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Analyses conducted at eye level. 1330 study eyes of 1090 participants underwent descemet stripping automated endothelial keratoplasty. 480 eyes completed bilateral surgery (240 participants), 1 participant had both eyes received cornea in 8-14 days group. 435 and 414 participants underwent unilateral surgery in 0-7 and 8-14 days groups.
| ID | Title | Description |
|---|---|---|
| BG000 | Preservation Time Group 1 | 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. |
| BG001 | Preservation Time Group 2 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| eyes |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years | eyes |
| ||||||||||||||
| Sex: Female, Male | Count of Units | eyes | eyes |
| |||||||||||||||
| Race/Ethnicity, Customized | Count of Units | eyes | eyes |
| |||||||||||||||
| History of Diabetes | Count of Units | eyes | eyes |
| |||||||||||||||
| Current cigarette smoker | Count of Units | eyes | eyes |
| |||||||||||||||
| Received any immunizations or vaccinations in last 3 mo | Count of Units | eyes | eyes |
| |||||||||||||||
| Prior glaucoma surgery | Count of Units | eyes | eyes |
| |||||||||||||||
| Glaucoma medication currently being used | Count of Units | eyes | eyes |
| |||||||||||||||
| Diagnosis | Count of Units | eyes | eyes |
| |||||||||||||||
| Corneal Dystrophy other than FECD (Fuchs endothelial corneal dystrophy)) | During the slit lamp exam performed using the investigator's usual routine, the presence of other corneal dystrophies was recorded; EBMD=epithelial basement membrane dystrophy | Count of Units | eyes | eyes |
| ||||||||||||||
| Stromal corneal vessels present (but not visually significant) | Count of Units | eyes | eyes |
| |||||||||||||||
| Central subepithelial/stromal scarring present (not affect postoperative stromal clarity assessment) | Count of Units | eyes | eyes |
| |||||||||||||||
| Peripheral anterior synechiae present (nongonioscopic) | Count of Units | eyes | eyes |
| |||||||||||||||
| Preoperative lens status | During the slit lamp exam performed using the investigator's usual routine, the state of the crystalline lens was described as phakic (present), aphakic (removed), or pseudophakic (removed with posterior chamber intraocular lens inserted) | Count of Units | eyes | eyes |
| ||||||||||||||
| Postoperative lens status | Count of Units | eyes | eyes |
| |||||||||||||||
| Intraocular pressure (IOP) | Median | Inter-Quartile Range | mm Hg | eyes |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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:
| Analyzed number of eyes in each group (Overall 1090 unique participants) | Posted | Count of Units | Eyes | Study eye will be assessed for this outcome for 3 years following surgery | Eyes | Eyes |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Endothelial Cell Density (ECD) | Endothelial cell density at 3 years from surgery, conditional on graft survival at 3 years from surgery. | Eyes with graft success and a gradable image at 3 year (945 eyes of 769 unique participants) | Posted | Mean | Standard Deviation | Cells per square millimeter | 3 years from surgery | eyes | eyes |
|
|
Through study completion, up to 5 years
Adverse event was collected at eye level
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 0-7d Preservation Time 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. | 20 | 675 | 1 | 675 | 0 | 675 |
| EG001 | 8-14d Preservation Time 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. | 32 | 654 | 2 | 654 | 0 | 654 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Endophthalmitis | Eye disorders | Systematic Assessment | One case of bacterial endophthalmitis occurred in the 0-7d PT group 4 days after surgery |
| |
| Microbial keratitis | Eye disorders | Systematic Assessment | Microbial keratitis (bacterial, fungal, parasitic) within 3 months of endothelial keratoplasty (EK) 2 cases of fungal keratitis occurred in the 8-14d PT group 13 and 43 days after surgery |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jonathan Lass | CaseWestern | 2168448368 | Jonathan.Lass@UHhospitals.org |
| Dec 4, 2017 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Male |
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| African American |
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| Hispanic or Latino |
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| Asian |
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| American India or Alaskan Native |
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| More than 1 race |
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| Unknown or not reported |
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| Aphakic corneal edema without FECD |
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| Fuchs endothelial corneal dystrophy (FECD) |
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| Keratoconus |
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| EBMD (epithelial basement membrane dystrophy) |
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| Other |
|
| Aphakic |
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| Pseudophakic posterior chamber intraocular lens |
|
| Pseudophakic posterior chamber intraocular lens |
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| Regression, Cox | Unadjusted Hazard Ratio | 0.02 | Hazard Ratio (HR) | 1.71 | 2-Sided | 95 | 1.09 | 2.71 | Other | Confounding and treatment interactions were assessed in Cox proportional hazards regression models |
| eyes |
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