Cornea Preservation Time Study

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 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