Cornea Preservation Time Study (CPTS)

Case Western Reserve University

Status and phase

Completed

Phase 4

Conditions

Endothelial Cell Density

Endothelial Keratoplasty

Cornea Preservation Time

Transplant Success

Treatments

Biological: Cornea tissue transplant

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01537393

CPTS

1U10EY020797-01A1 (U.S. NIH Grant/Contract)

1U10EY020798-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,174 patients

Sex

All

Ages

30 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

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