Cornea Preservation Time Study

NCT ID: NCT01537393

Last Updated: 2018-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1174 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-16
• Study Completion Date: 2017-06-30

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

0-7d Preservation Time Group

Subjects in this arm will receive cornea tissue transplant with cornea tissue preserved for 0 to 7 days prior to transplant.

Group Type: OTHER

Cornea tissue transplant

Intervention Type: BIOLOGICAL

Cornea tissue preserved 0 to 7 days

8-14d Preservation Time Group

Subjects in this arm will receive cornea tissue transplant with cornea tissue preserved for 8 to 14 days prior to transplant.

Group Type: OTHER

Cornea tissue transplant

Intervention Type: BIOLOGICAL

Cornea tissue preserved 8 to 14 days.

Interventions

Cornea tissue transplant

Cornea tissue preserved 0 to 7 days

Intervention Type: BIOLOGICAL

Cornea tissue transplant

Cornea tissue preserved 8 to 14 days.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

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

Exclusion Criteria

Study Eye Eligibility 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

3. EK surgery in second eye is not planned within 6 weeks of EK on first study eye

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Eye Institute (NEI)

NIH

Sponsor Role: collaborator

Jaeb Center for Health Research

OTHER

Sponsor Role: collaborator

Case Western Reserve University

OTHER

Sponsor Role: lead

Responsible Party

Jonathan Lass, MD

Charles I Thomas Professor, Dept. of Ophthalmology & Visual Sciences,

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jonathan Lass, MD

Role: STUDY_CHAIR

Case Western Reserve University

Allison Ayala, MS

Role: PRINCIPAL_INVESTIGATOR

Jaeb Center for Health Research

Locations

Keck Medical Center

Beverly Hills, California, United States

Jules Stein Eye Institute

Los Angeles, California, United States

Eye Care of San Diego

San Diego, California, United States

University of California, San Francisco

San Francisco, California, United States

Bascom Palmer Eye Institute

Miami, Florida, United States

Center for Sight

Sarasota, Florida, United States

Woolfson Eye Institute

Atlanta, Georgia, United States

Eye Consultants of Atlanta

Atlanta, Georgia, United States

University of Illinois Eye and Eye

Chicago, Illinois, United States

NorthShore University Health System

Glenview, Illinois, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

University of Kentucky Ophthalmology

Lexington, Kentucky, United States

Mid-Atlantic Cornea Consultants

Baltimore, Maryland, United States

Johns Hopkins/Wilmer Eye Institute

Baltimore, Maryland, United States

Eye Consultants of Maryland

Owings Mills, Maryland, United States

Ophthalmic Consultants of Boston

Boston, Massachusetts, United States

University of Michigan/Kellogg Eye Center

Ann Arbor, Michigan, United States

Verdier Eye Center

Grand Rapids, Michigan, United States

Michigan Cornea Consultants

Southfield, Michigan, United States

Minnesota Eye Consultants

Bloomington, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

Mercy Medical Research Institute

Springfield, Missouri, United States

Ophthalmology Associates

St Louis, Missouri, United States

New York Eye and Ear Infirmary

New York, New York, United States

Cornea Consultants of Albany

Slingerlands, New York, 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

Northeast Ohio Eye Surgeons

Kent, Ohio, United States

Medical Eye Center

Medford, Oregon, United States

Devers Eye Institute

Portland, Oregon, United States

Ophthalmic Partners of PA

Bala-Cynwyd, Pennsylvania, United States

Central Pennsylvania Eye Institute

Hershey, Pennsylvania, United States

Sadeer Hannush, MD

Langhorne, Pennsylvania, United States

Corneal Associates, PC, Wills Eye Institute

Philadelphia, Pennsylvania, United States

Cornea Associates of Texas

Dallas, Texas, United States

Focal Point Vision

San Antonio, Texas, United States

University of Utah, Moran Eye Center

Salt Lake City, Utah, United States

Eye Associates Northwest

Seattle, Washington, United States

Dean Medical Center

Madison, Wisconsin, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 29127431 (View on PubMed)

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.

Reference Type: RESULT

PMID: 29127432 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36036663 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25850706 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://cpts.jaeb.org/

Public website

Other Identifiers

1U10EY020798-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1U10EY020797-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CPTS

Identifier Type: -

Identifier Source: org_study_id