RECRUITING

Glaucoma Drainage Device and Endothelial Cell Loss Compare Trial

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

Glaucoma Drainage Device and Endothelial Cell Loss Compare Trial (DECLARE) is a multi-center, outcome-masked, randomized clinical trial. The purpose of this study is to compare glaucoma drainage device implantation in the anterior chamber (front part of the eye) and sulcus (small space between iris and front chamber of the eye) in efforts to minimize cell loss in the eye.

Official Title

Glaucoma Drainage Device and Endothelial Cell Loss Compare Trial

Quick Facts

Study Start:2023-07-11
Study Completion:2027-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05924477

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 CriteriaExclusion Criteria
  1. * Medically uncontrolled glaucoma requiring GDD or GDD combined with phacoemulsification as the planned surgical procedure
  2. * Candidate for GDD implantation for ciliary sulcus and AC tube
  3. * Age greater than or equal to 18 years old
  1. * Preexisting corneal condition that would affect the corneal endothelium or previous corneal transplant
  2. * Previous GDD implantation or Xen Gel Stent or placement of Cypass Micro-stent or Preserflo MicroShunt
  3. * Previous trabeculectomy and/or minimally invasive glaucoma surgery within the past 6 months
  4. * AC intraocular lens
  5. * Presence of nanophthalmos, uncontrolled uveitis, silicone oil, Sturge-Weber syndrome or other conditions associated with elevated episcleral venous pressure
  6. * Unwilling or unable to give consent, unwilling to accept randomization, or unable to return for scheduled protocol visits
  7. * No light perception vision in the study eye or fellow eye visual acuity \< 20/200
  8. * Need for glaucoma surgery combined with other ocular procedures (i.e. corneal transplant, or retinal surgery) or anticipated need for additional ocular surgery

Contacts and Locations

Study Contact

Gui-shuang Ying, PhD
CONTACT
215-615-1514
gsying@pennmedicine.upenn.edu

Principal Investigator

Ying Han, MD, PhD
STUDY_CHAIR
University of California, San Francisco
Jennifer Rose-Nussbaumer, MD
STUDY_DIRECTOR
Stanford University
Thuy Doan, MD, PhD
STUDY_DIRECTOR
University of California San Fransicso

Study Locations (Sites)

University of California San Francisco
San Francisco, California, 94143
United States
Bascom Palmer Eye Institute
Miami, Florida, 33136
United States
Massachusetts Eye and Ear
Boston, Massachusetts, 02114
United States
University of Buffalo/State University of New York
Buffalo, New York, 14203
United States

Collaborators and Investigators

Sponsor: University of Pennsylvania

  • Ying Han, MD, PhD, STUDY_CHAIR, University of California, San Francisco
  • Jennifer Rose-Nussbaumer, MD, STUDY_DIRECTOR, Stanford University
  • Thuy Doan, MD, PhD, STUDY_DIRECTOR, University of California San Fransicso

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 Date2023-07-11
Study Completion Date2027-12

Study Record Updates

Study Start Date2023-07-11
Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

  • glaucoma
  • glaucoma drainage device
  • endothelial cell density
  • endothelial cell loss
  • intraocular pressure

Additional Relevant MeSH Terms

  • Glaucoma