Clinical Trials

Inclusion Criteria - Participant:

• Age range 30- < 91 years with minimum life expectancy of at least 1 year.
• Willingness to return to study site for follow up at 1 month and 1 year.
• Fluent in English or Spanish.
• Willingness to have fingerstick blood sample collected to determine HbA1c level at entry and at 1 year. If determined to be diabetic at baseline, participant will be advised to seek medical care.

Inclusion Criteria - Study Eye:

• Clinically recommended for DMEK, and able to schedule DMEK between 5 to 90 days after enrollment.
• Presence of a condition related to endothelial dysfunction which will be treated by DMEK.  Eligible indications for DMEK include:
  • 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;
  • Pseudophakic FECD with posterior capsule supported, sulcus supported, or scleral-fixated posterior chamber IOL b. Pseudophakic corneal edema with posterior capsule supported, sulcus supported, or scleral-fixated posterior chamber IOL without FECD;
  • Failed Descemet stripping automated endothelial keratoplasty (DSAEK) or DMEK without exclusionary criteria, as described below.

Exclusion Criteria:

• Pregnant or planning to become pregnant prior to the DMEK study surgery, based on verbal report.
• Lack cognitive capacity such that consent could not be provided.
• Presence of a condition that has a high probability for failure (e.g., failed penetrating keratoplasty, uncontrolled uveitis).
• Stromal vascularization that will impede assessment of recipient stroma clarity.
• Other primary endothelial dysfunction conditions including posterior polymorphous corneal dystrophy and congenital hereditary corneal dystrophy.
• Indication for surgery that is not suitable for DMEK (e.g, keratoconus, stromal dystrophies and scars).
• Aphakic corneal edema with or without FECD.
• Anterior chamber IOL in study eye prior to DMEK or planned placement of anterior chamber IOL during DMEK.
• Planned IOL exchange of an anterior chamber IOL with a posterior chamber IOL in study eye at time of study DMEK.
• Pre-operative central sub-epithelial or stromal scarring that could impact post-operative recipient stromal clarity assessment.
• Presence of anterior synechiae.
• Peripheral anterior synechiae in the angle greater than a total of three clock hours.
• Uncontrolled glaucoma with or without prior filtering surgery, tube shunt placement, or MIGS. Uncontrolled glaucoma is defined as intraocular pressure > 25mm Hg.
• Controlled glaucoma with prior tube shunt placement for glaucoma (controlled glaucoma with MIGS is allowed).
• Fellow eye visual acuity < 20/200 due to an ocular condition other than a cornea disease that would be a candidate for DMEK.
• IOP < 8 mmHg.
• Topical Rho kinase inhibitor, including Rhopressa, used within 1 month prior to study entry and anticipated during the course of the study.

Eligibility last updated 5/18/22. Questions regarding updates should be directed to the study team contact.