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Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

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.

Details

Corneal transplantation has evolved rapidly in recent years. Lamellar keratoplasty to replace diseased endothelium has led to faster recovery times, fewer complications, and better visual acuity outcomes. Currently, Descemet's Stripping Endothelial Keratoplasty (DSAEK) is the most common procedure because of its relative ease and good outcomes. Newer techniques such as Descemet's Membrane Endothelial Keratoplasty (DMEK), where Descemet's membrane alone is transplanted, has the potential to further improve visual acuity outcomes, produce fewer higher-order corneal aberrations and decrease rejection rates. However, donor preparation, increased intra-operative times, and problems with donor attachment in DMEK are all important limitations.

There are three potential mechanisms by which DMEK may provide better visual acuity outcomes than DSAEK; graft thickness, interface haze and corneal higher-order aberrations. Graft thickness has been correlated with best spectacle corrected visual acuity (BSCVA) outcomes among thinner grafts. One retrospective case series found that 71% of thin endothelial grafts (defined as <131μm) had BSCVA of 20/25 or better while only 50% of thick grafts (defined as ≥131) achieved this. In addition, higher-order aberrations, in particular of the posterior cornea, are increased after DSAEK. Theoretically, given the decreased tissue transplanted after DMEK this would be lessened, however, one retrospective series looking at higher order aberrations in DMEK compared with DSAEK found no difference in posterior aberrations of the central 4.0 mm zone between the two groups. Finally, interface haze may be increased in DSAEK and has been correlated with BSCVA.

Ultrathin DSAEK involves donor preparation with a deep microkeratome pass to produce donor grafts less than 100 um thick. This procedure may have similar results to DMEK but without the technical difficulties. Several large prospective series show similar visual outcome results and rates of immunologic rejection between ultrathin DSAEK and DMEK, however comparisons are difficult. This comparative effectiveness clinical trial could directly address these important issues. The investigators also anticipate that secondary analyses of the trial data will allow us to address several more.

Keywords

Keratoplasty Grafting, Corneal Transplantation, Corneal Transplantation, Cornea Keratoplasty, Lamellar Prednisolone acetate Methylprednisolone acetate Prednisolone Methylprednisolone Methylprednisolone Hemisuccinate Prednisolone hemisuccinate Prednisolone phosphate Ofloxacin Levofloxacin Phenylephrine Oxymetazoline Tropicamide

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • F. I. Proctor Foundation, University of California, San Francisco
    San Francisco, California, 94143, United States
  • Byers Eye Institute, Stanford University
    Palo Alto, California, 94303, United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Winston Chamberlain, MD, PhD
ID
NCT02373137
Phase
Phase 4
Lead Scientist
Jennifer Rose-Nussbaumer
Study Type
Interventional
Last Updated
April 14, 2017