Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
This double-masked multi-center trial will evaluate the association of diabetes in the cornea
donor with transplant success and loss of endothelial cells one year following Descemet
membrane endothelial keratoplasty (DMEK). Study eyes will be assigned to receive either a
cornea from a donor without diabetes or a cornea from a donor with diabetes.
Phase
Phase 3
Funding Agency/Sponsor
Other
Disease
Other
Enrollment Eligibility
Participant Inclusion Criteria:
1. Age range 30- < 91 years with minimum life expectancy of at least 1 year
2. Willingness to return to study site for follow up at 1 month and 1 year
3. Fluent in English or Spanish
4. Willingness to have fingerstick blood sample collected to determine HbA1c level at
entry and at 1 year. The participant must agree to have their primary care provider
contacted (or an appropriate referral provided) if they were not known to have
diabetes and the HbA1c suggests they may have diabetes. Similarly, if already known to
have diabetes and the HbA1c is high, the participant must agree to have their primary
care provider contacted or an appropriate referral provided.
5. Has at least one eye clinically recommended for DMEK that is able to be scheduled for
DMEK between 5 to 90 days after enrollment. If second eye is enrolled, it must be
scheduled for DMEK between 7 days and 6 months after DMEK on the first eye.
6. Has a condition related to endothelial dysfunction which will be treated by DMEK.
Eligible indications for DMEK include:
1. Presence of Fuchs endothelial corneal dystrophy (FECD) meeting at least one of
the following: phakic FECD with or without cataract (triple procedure including
DMEK for FECD, cataract extraction and posterior chamber intraocular lens
implantation (IOL) is allowed)
2. pseudophakic FECD with posterior capsule supported, sulcus supported, or
scleral-fixated posterior chamber IOL
3. pseudophakic corneal edema with posterior capsule supported, sulcus supported, or
scleral-fixated posterior chamber IOL without FECD
4. failed Descemet stripping automated endothelial keratoplasty (DSAEK) or DMEK
originally performed for the same indications above without current exclusionary
criteria, as described below
Exclusion Criteria:
1. Pregnant or planning to become pregnant prior to the DMEK study surgery, based on
verbal report.
2. Lack cognitive capacity such that consent could not be provided.
3. Presence of a condition that has a high probability for failure (e.g., failed
penetrating keratoplasty, uncontrolled uveitis)
4. Stromal vascularization that will impede assessment of recipient stroma clarity
5. Other primary endothelial dysfunction conditions including posterior polymorphous
corneal dystrophy and congenital hereditary corneal dystrophy.
6. Indication for surgery that is not suitable for DMEK (e.g, keratoconus, stromal
dystrophies and scars)
7. Aphakic corneal edema with or without FECD
8. Anterior chamber IOL in study eye prior to DMEK or planned placement of anterior
chamber IOL during DMEK
9. Presence of vitreous in the anterior chamber
10. Planned IOL exchange of an anterior chamber IOL with a posterior chamber IOL in study
eye at time of study DMEK
11. Pre-operative central sub-epithelial or stromal scarring that could impact
post-operative recipient stromal clarity assessment
12. Presence of anterior synechiae
13. Peripheral anterior synechiae in the angle greater than a total of three clock hours
14. Uncontrolled glaucoma with or without prior filtering surgery, tube shunt placement,
or MIGS. Uncontrolled glaucoma is defined as intraocular pressure > 25mm Hg.
15. Controlled glaucoma with prior tube shunt placement for glaucoma (controlled glaucoma
with minimally invasive glaucoma surgery (MIGS) or trabeculectomy is allowed)
16. Fellow eye visual acuity < 20/200 due to an ocular condition other than a cornea
disease that would be a candidate for DMEK
17. Intraocular pressure <8 mmHg
18. Topical Rho kinase inhibitor, including netarsudil, used within 1 month prior to study
entry and anticipated during the course of the study
19. Fellow eye enrolled in the DEKS that has met study-criteria for graft failure.