Descemet Endothelial Thickness Comparison Trial
Condition: Keratoplasty; Grafting, Corneal; Transplantation, Corneal; Transplantation, Cornea; Keratoplasty, Lamellar
Intervention: DSAEK; DMEK; Endoserter; Prednisolone; Ofloxacin; Tropicamide; Phenylephrine; Jones Tube
Intervention description: The Endoserter, a corneal endothelium device, is an approved FDA device. This will be used to insert and position the graft into the anterior chamber during endothelial replacement surgery. It is a sterile, single-use instrument.; Prednisolone is a corticosteroid used to alleviate swelling post-surgery.; Ofloxacin is an antibiotic used to treat bacterial infections of the eye.; Tropicamide is a prescription drug used to dilate pupils during an eye exam.; Phenylephrine is a prescription drug used to dilate pupils during an eye exam.; The Jones Tube will be used to insert the graft into a 3.5 mm corneal incision during endothelial replacement surgery.
Intervention MeSH terms: Ofloxacin; Prednisolone; Phenylephrine; Oxymetazoline; Tropicamide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare visual acuity outcomes of two types of endothelial
      keratoplasty: 1) Ultrathin Descemet's Stripping Endothelial Keratoplasty (DSAEK) or 2)
      Descemet's Membrane Endothelial Keratoplasty (DMEK). Half of the participants will be
      randomized to have DSAEK and the other half will have DMEK.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Damaged or diseased endothelium from Fuchs or Pseudophakic Bullous Keratopathy

          -  Good candidates for corneal transplantation for either DMEK or DSAEK

          -  Willingness and ability to undergo a cornea transplantation

          -  Willingness to participate in follow-up visits

        Exclusion Criteria:

          -  Participants who are decisionally and/or cognitively impaired

          -  Participants who are not suitable for the DMEK or DSAEK surgeries

          -  Prior Endothelial Keratoplasty (EK) or any other ophthalmic surgery except
             uncomplicated cataract surgery

          -  Indication for surgery that is not suitable for EK (e.g. keratoconus, stromal
             dystrophies and scars)

          -  Presence of a condition that increases the probability for failure (e.g., heavily
             vascularized cornea, uncontrolled uveitis)

          -  Other primary endothelial dysfunction conditions including posterior polymorphous
             corneal dystrophy and congenital hereditary corneal dystrophy

          -  Aphakia, or anterior chamber intraocular lens (IOL) in study eye prior to or
             anticipated during EK

          -  Planned intraocular lens exchange of an anterior chamber IOL with a posterior chamber
             IOL in study at time of study EK

          -  Pre-operative central sub-epithelial or stromal scarring that the investigator
             believes is visually significant and could impact post-operative stromal clarity
             assessment

          -  Peripheral anterior synechiae (iris to angle) in the angle greater than a total of
             three clock hours

          -  Hypotony (Intraocular pressure <10mmHg)

          -  Uncontrolled (defined as intraocular pressure >25mmHg) glaucoma Visually significant
             optic nerve or macular pathology

          -  Visually significant optic nerve or macular pathology