Descemet Endothelial Thickness Comparison Trial I

Launched by STANFORD UNIVERSITY · Mar 15, 2022

Keywords

ClinConnect Summary

The Descemet Endothelial Thickness Comparison Trial (DETECT) I is a clinical study looking at two types of corneal transplant surgeries to help improve vision in patients with certain eye conditions, particularly Fuchs Endothelial Corneal Dystrophy (FECD). The trial aims to compare the outcomes of ultrathin Descemet stripping automated endothelial keratoplasty (UT-DSAEK) and Descemet membrane endothelial keratoplasty (DMEK). Additionally, it will explore how certain medications, called rho-kinase inhibitors, might help reduce the loss of important cells in the eye after surgery.

To participate in the study, you need to be over 18 years old and have a specific eye condition that affects the cornea, such as FECD with significant damage, or other conditions like pseudophakic corneal edema or iridocorneal endothelial syndrome. Participants should be willing to undergo surgery and follow study guidelines, including using the study medications. If you join the trial, you will receive either one of the surgeries and possibly the medication, with regular follow-up visits to monitor your progress. This study is currently recruiting participants and aims to help improve treatment options for those with corneal issues.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Dysfunctional endothelium from Fuchs Endothelial Corneal Dystrophy (FECD) with guttata extending beyond 4.5 mm of the central cornea or severe edema without visualization of guttata
• • Dysfunctional endothelium from Pseudophakic Corneal Edema (PCE) or Iridocorneal Endothelial Syndrome (ICE) or other primary endothelial dysfunction such as Posterior Polymorphous Corneal Dystrophy (PPMD)
• • Dysfunctional endothelium from prior graft failure after PKP or EK
• • Controlled uveitis (defined as quiet for \> 3 months off of topical steroids with or without systemic immunosuppression) or no uveitis
• • Controlled glaucoma with topical medications and/or prior trabeculectomy or tube shunt without ongoing hypotony (IOP \< 5 mmHg) or no glaucoma
• • Good candidate for corneal transplantation for either DMEK or UT-DSAEK
• • Willingness to participate
• • Age greater than 18 years
• Exclusion Criteria:
• • Aphakia, or anterior chamber IOL or scleral fixated IOL in study eye prior to or anticipated during 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
• • Visually significant optic nerve (ok to have small visual field defects) or macular severe pathology
• • Pregnancy