RECRUITING

Descemet Endothelial Thickness Comparison Trial II

Conditions

Fuchs Fuchs Dystrophy Fuchs' Endothelial Dystrophy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Descemet Endothelial Thickness Comparison Trials (DETECT I & II)

Quick Facts

Study Start:2023-01-23

Study Completion:2027-11-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05275972

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Nicole Varnado, MPH

CONTACT

650-725-1688

nvarnado@stanford.edu

Maalika Kanchugantla, MPH

CONTACT

maalikaa@stanford.edu

Principal Investigator

Jennifer Rose-Nussbaumer, MD

PRINCIPAL_INVESTIGATOR

Stanford University

Study Locations (Sites)

Stanford University

Palo Alto, California, 94303

United States

University of California Davis

Sacramento, California, 95817

United States

University of Miami

Palm Beach Gardens, Florida, 33418

United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03766

United States

Oregon Health & Science University

Portland, Oregon, 97239

United States

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

Wills Eye Hospital

Philadelphia, Pennsylvania, 19107

United States

Collaborators and Investigators

Sponsor: Stanford University

Jennifer Rose-Nussbaumer, MD, PRINCIPAL_INVESTIGATOR, Stanford University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-23

Study Completion Date2027-11-30

Study Record Updates

Study Start Date2023-01-23

Study Completion Date2027-11-30

Terms related to this study

Additional Relevant MeSH Terms

Fuchs
Fuchs Dystrophy
Fuchs' Endothelial Dystrophy