CI

At a glance

ClinicalIndex Comparison Record
Phase 4Unknown· 38 enrolled
Drug / intervention
Prednisolone +7 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02373137
NCT02373137Phase 4Unknown
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Descemet Endothelial Thickness Comparison Trial

Oregon Health and Science University·interventional·Posted Feb 26, 2015·Updated Nov 25, 2020

In Brief

A Phase 4 clinical trial evaluating DSAEK, DMEK, and 6 other interventions for Keratoplasty and 4 related conditions. Targeting 38 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKeratoplasty, Grafting, Corneal, Transplantation, Corneal, Transplantation, Cornea, Keratoplasty, Lamellar
CountriesUnited States
CollaboratorsUniversity of California, San Francisco, Stanford University

Timeline

Phase 4UnknownOverdue
201520162017201820192020202120222023202420252026
First PostedFeb 26, 2015
Enrollment StartJan 22, 2015
Primary CompletionApr 4, 2018
Study CompletionMay 30, 2023
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 11.3 years ago

Interventions

DSAEKprocedure

DMEKprocedure

Endoserterdevice

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.

Prednisolonedrug

Prednisolone is a corticosteroid used to alleviate swelling post-surgery.

Ofloxacindrug

Ofloxacin is an antibiotic used to treat bacterial infections of the eye.

Tropicamidedrug

Tropicamide is a prescription drug used to dilate pupils during an eye exam.

Phenylephrinedrug

Phenylephrine is a prescription drug used to dilate pupils during an eye exam.

Jones Tubedevice

The Jones Tube will be used to insert the graft into a 3.5 mm corneal incision during endothelial replacement surgery.