Descemet Endothelial Thickness Comparison Trial II

Description

Descemet Endothelial Thickness Comparison Trial (DETECT) II is a multi-center, outcome assessor-masked, placebo-controlled clinical trial randomizing 60 patients with Fuchs endothelial dystrophy to DMEK versus Descemet Stripping Only (DSO) with adjunctive Ripasudil.

Conditions

Fuchs, Fuchs Dystrophy, Fuchs' Endothelial Dystrophy

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Study Overview

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Study Details

Study overview

Descemet Endothelial Thickness Comparison Trial (DETECT) II is a multi-center, outcome assessor-masked, placebo-controlled clinical trial randomizing 60 patients with Fuchs endothelial dystrophy to DMEK versus Descemet Stripping Only (DSO) with adjunctive Ripasudil.

Descemet Endothelial Thickness Comparison Trials (DETECT I & II)

Descemet Endothelial Thickness Comparison Trial II

Condition
Fuchs
Intervention / Treatment

-

Contacts and Locations

Palo Alto

Stanford University, Palo Alto, California, United States, 94303

Sacramento

University of California Davis, Sacramento, California, United States, 95817

Palm Beach Gardens

University of Miami, Palm Beach Gardens, Florida, United States, 33418

Lebanon

Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States, 03766

Portland

Oregon Health & Science University, Portland, Oregon, United States, 97239

Philadelphia

University of Pennsylvania, Philadelphia, Pennsylvania, United States, 19104

Philadelphia

Wills Eye Hospital, Philadelphia, Pennsylvania, United States, 19107

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Dysfunctional endothelium from FECD with few guttata extending beyond 4.5 mm
  • * Peripheral endothelial cell count \>1500 cells/mm2
  • * Good surgical candidate for either procedure as determined by the surgeon
  • * Willingness and ability to undergo corneal transplantation
  • * Willingness to consistently use study medications (i.e. ROCK-inhibitors)
  • * Willingness to participate in follow-up visits
  • * Age greater than 18 years
  • * Other primary endothelial dysfunction such as PPMD
  • * Any prior intraocular surgery other than cataract surgery
  • * Cataract surgery within the last 3 months
  • * \>3 clock hours of ANY anterior or posterior synechiae
  • * \>1 quadrant of stromal corneal vascularization
  • * Visually significant optic nerve or macular pathology
  • * Fellow eye visual acuity \<20/200
  • * Pregnancy
  • * Inability to comply with post-operative instructions (i.e. unable to position)
  • * Hypotony (Intraocular pressure \<10mmHg)
  • * Peripheral anterior synechiae (iris to angle) in the angle greater than a total of three clock hours
  • * Aphakia, 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Stanford University,

Jennifer Rose-Nussbaumer, MD, PRINCIPAL_INVESTIGATOR, Stanford University

Study Record Dates

2027-11-30