Cornea Preservation Time Clinical Trial
— CPTSOfficial title:
Effect of Corneal Preservation Time on Long-Term Graft Success
| Verified date | April 2018 |
| Source | Case Western Reserve University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 1174 |
| Est. completion date | June 30, 2017 |
| Est. primary completion date | June 30, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 30 Years to 90 Years |
| Eligibility |
Study Participant Eligibility Criteria - Study Participant Inclusion Criteria 1. Age range 30-<91 years with minimum life expectancy of at least 3 years. 2. Willingness to return for follow-up study visits at 1 day, 1 week, 1 month, 6 months, 1 year, 2 years and 3 years. 3. Fluent in English or Spanish. - Study Participant Exclusion Criteria 1) Decisionally and/or cognitively impaired Study Eye Eligibility Criteria - Study Eye Inclusion Criteria 1. 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. 2. 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 1. Prior EK 2. Indication for surgery that is not suitable for EK (e.g, keratoconus, stromal dystrophies and scars) 3. 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) 4. Other primary endothelial dysfunction conditions including posterior polymorphous corneal dystrophy and congenital hereditary corneal dystrophy 5. Anterior chamber IOL in study eye prior to or anticipated during EK 6. Planned intraocular lens exchange of an anterior chamber IOL with a posterior chamber IOL in study eye at time of study EK 7. Pre-operative central sub-epithelial or stromal scarring that the investigator believes is visually significant and could impact post-operative stromal clarity assessment 8. Stromal vascularization that is visually significant (by investigator's judgment) 9. Presence of anterior synechiae (iris to cornea) 10. Peripheral anterior synechiae (iris to angle) in the angle greater than a total of three clock hours 11. Hypotony (Intraocular pressure <10 mm Hg) 12. 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. 13. 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 14. Fellow eye visual acuity < 20/200 that is not correctable with EK Eligibility Criteria for Second Study Eye 1. Study participant has already enrolled one eye 2. The second eye meets all study eye inclusion and exclusion criteria (2.2.2 and 2.2.3) 3. EK surgery in second eye is not planned within 6 weeks of EK on first study eye |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Michigan/Kellogg Eye Center | Ann Arbor | Michigan |
| United States | Eye Consultants of Atlanta | Atlanta | Georgia |
| United States | Woolfson Eye Institute | Atlanta | Georgia |
| United States | Ophthalmic Partners of PA | Bala-Cynwyd | Pennsylvania |
| United States | Johns Hopkins/Wilmer Eye Institute | Baltimore | Maryland |
| United States | Mid-Atlantic Cornea Consultants | Baltimore | Maryland |
| United States | Keck Medical Center | Beverly Hills | California |
| United States | Minnesota Eye Consultants | Bloomington | Minnesota |
| United States | Ophthalmic Consultants of Boston | Boston | Massachusetts |
| United States | University of Illinois Eye and Eye | Chicago | Illinois |
| United States | Cincinnati Eye Institute | Cincinnati | Ohio |
| United States | University Hospitals Case Medical Center Eye Institute | Cleveland | Ohio |
| United States | Ohio State Medical Center | Columbus | Ohio |
| United States | Cornea Associates of Texas | Dallas | Texas |
| United States | NorthShore University Health System | Glenview | Illinois |
| United States | Verdier Eye Center | Grand Rapids | Michigan |
| United States | Central Pennsylvania Eye Institute | Hershey | Pennsylvania |
| United States | University of Iowa Hospitals and Clinics | Iowa City | Iowa |
| United States | Northeast Ohio Eye Surgeons | Kent | Ohio |
| United States | Sadeer Hannush, MD | Langhorne | Pennsylvania |
| United States | University of Kentucky Ophthalmology | Lexington | Kentucky |
| United States | Jules Stein Eye Institute | Los Angeles | California |
| United States | Dean Medical Center | Madison | Wisconsin |
| United States | Medical Eye Center | Medford | Oregon |
| United States | Bascom Palmer Eye Institute | Miami | Florida |
| United States | New York Eye and Ear Infirmary | New York | New York |
| United States | Eye Consultants of Maryland | Owings Mills | Maryland |
| United States | Corneal Associates, PC, Wills Eye Institute | Philadelphia | Pennsylvania |
| United States | Devers Eye Institute | Portland | Oregon |
| United States | Mayo Clinic | Rochester | Minnesota |
| United States | Ophthalmology Associates | Saint Louis | Missouri |
| United States | University of Utah, Moran Eye Center | Salt Lake City | Utah |
| United States | Focal Point Vision | San Antonio | Texas |
| United States | Eye Care of San Diego | San Diego | California |
| United States | University of California, San Francisco | San Francisco | California |
| United States | Center for Sight | Sarasota | Florida |
| United States | Eye Associates Northwest | Seattle | Washington |
| United States | Cornea Consultants of Albany | Slingerlands | New York |
| United States | Michigan Cornea Consultants | Southfield | Michigan |
| United States | Mercy Medical Research Institute | Springfield | Missouri |
| Lead Sponsor | Collaborator |
|---|---|
| Case Western Reserve University | Jaeb Center for Health Research, National Eye Institute (NEI) |
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 End — View Citation
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 Pres — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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: 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. |
Study eye will be assessed for this outcome for 3 years following surgery | |
| Primary | 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 |