# Glaucoma Drainage Device and Endothelial Cell Density Loss Compare (DECLARE) Trial

> **NIH NIH UG1** · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · 2024 · $1,049,710

## Abstract

PROJECT SUMMARY/ABSTRACT
 Glaucoma drainage device (GDD) surgery has gained popularity in managing patients with medically
uncontrolled glaucoma. However, one of the major long-term complications of GDD is progressive corneal
endothelial cell loss (ECL) leading to corneal decompensation, which requires complex care. Although surgical
techniques have been modified to insert the tube into the ciliary sulcus to address this issue, anterior chamber
(AC) tube placement remains the preferred location, as there is a lack of convincing data to validate the
advantages of sulcus placement. For example, (1) Direct comparison of endothelial cell loss (ECL) after sulcus
versus AC tube placement is limited to three retrospective studies; (2) Studies are inconsistent regarding
whether intraocular pressure (IOP) and other surgical outcomes are similar after sulcus tube or AC tube
placement; (3) Question remains whether a sulcus tube cause more AC microenvironment change due to
higher chance of having chronic tube-iris touch than an AC tube, jeopardizing endothelial cell health, IOP
control, or other surgical outcomes of the sulcus tube.
 To answer these questions, we propose a multi-center, outcome-masked clinical trial randomizing 240
subjects to sulcus tube versus AC tube placement. In this trial, we will compare ECL (specific aim 1), IOP
control (specific aim 2) and AC microenvironment (specific aim 3) after GDD implantation with tube placement
in the ciliary sulcus versus the anterior chamber. In the setting of increased use of GDDs, our proposed trial to
identify better approaches to decrease its corneal complications is of substantial interest to both corneal and
glaucoma specialists.
 Department of Ophthalmology at University of California San Francisco (UCSF), Francis I. Proctor
Foundation at UCSF, University of Pennsylvania (UPenn), and 4 high-volume centers for GDD implantation will
jointly execute this trial. The Department of Ophthalmology at UCSF will serve as Clinical Coordinating Center.
UPenn will be the Data Coordinating Center. Francis I. Proctor Foundation will be the imaging reading center
and metagenomic RNA deep sequencing analysis (MDS) center.
 This trial is innovative for a number of reasons including the randomization of surgery (sulcus tube
versus AC tube) and application of novel MDS analysis (examining postoperative AC microenvironment), none
of which has been prospectively studied before. It is aligned with the priorities of the NEI, studying high-
resolution imaging techniques such as endothelial cell imaging and anterior-segment optical coherence to
guide post-operative treatment and as potential surrogate trial endpoints in future trials. This world class team
of collaborators have a proven track record for executing large NEI-funded trials in ophthalmology, and are well
positioned to answer the important questions presented in this proposal.

## Key facts

- **NIH application ID:** 10818328
- **Project number:** 5UG1EY033703-02
- **Recipient organization:** UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
- **Principal Investigator:** Ying Han
- **Activity code:** UG1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $1,049,710
- **Award type:** 5
- **Project period:** 2023-04-01 → 2028-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10818328

## Citation

> US National Institutes of Health, RePORTER application 10818328, Glaucoma Drainage Device and Endothelial Cell Density Loss Compare (DECLARE) Trial (5UG1EY033703-02). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10818328. Licensed CC0.

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