Glaucoma
Conditions
Keywords
glaucoma, glaucoma drainage device, endothelial cell density, endothelial cell loss, intraocular pressure
Brief summary
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.
Detailed description
The DECLARE Trial is a prospective 1:1 randomized, parallel design, double-masked clinical trial to compare endothelial cell density (ECD), intraocular pressure (IOP) and metagenomic RNA deep sequencing (MDS) between sulcus and anterior chamber (AC) tube placement after glaucoma drainage device (GDD) implantation. The trial has fixed sample size with 12 months follow-up for primary outcome assessment and trial participants will continue to be followed to the end of grant cycle with a total of 24 months follow-up. Patients will be randomized to 2 tube locations for GDD implantation: * Tube placed in the AC * Tube placed in ciliary sulcus * Stratification: by clinical center and type of surgery (GDD alone vs GDD combined with phacoemulsification). Stratified randomization by clinical center is to ensure that a similar number of subjects will be randomized to either sulcus tube or AC tube placement for a specific clinical center. Because eyes undergoing a combined phacoemulsification with GDD implantation may be associate with larger ECL from phacoemulsification, stratified by surgery type is to ensure two tube location groups similar number of study eyes that will undergo a combined phacoemulsification with GDD implantation.
Interventions
PROCEDURESulcus tube placement
GDD implantation surgery with tube placement in the ciliary sulcus
PROCEDUREAnterior chamber (AC) tube placement
GDD implantation surgery with tube placement in the anterior chamber
Sponsors
University of Pennsylvania
National Eye Institute (NEI)
University of California, San Francisco
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
All trial participants will be masked to their tube locations. The primary outcome accessors who grade specular microscopy images at the PRC, perform IOP measurements at each clinical center, or conduct the MDS analysis at the Metagenomic RNA Deep Sequencing (RNA-seq) Center will also be masked to tube locations. Due to the nature of the surgical intervention, the surgeon, the technician taking specular microscopy and AS-OCT images, and the graders at the PRC who will perform AS-OCT measurements will not be masked to the tube locations. However, the graders of AS-OCT images will be masked to the purpose of the study and will be different from the graders of specular microscopy images.
Intervention model description
A prospective 1:1 randomized, parallel design, double-masked clinical trial. Stratification is by clinical center and type of surgery (GDD alone vs GDD combined with phacoemulsification).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Medically uncontrolled glaucoma requiring GDD or GDD combined with phacoemulsification as the planned surgical procedure * Candidate for GDD implantation for ciliary sulcus and AC tube * Age greater than or equal to 18 years old
Exclusion criteria
* Preexisting corneal condition that would affect the corneal endothelium or previous corneal transplant * Presence or history of Cypass Micro-Stent * Previous GDD, Xen Gel Stent or Preserflo MicroShunt removed less than 6 months before surgery * Presence of GDD implantation, Xen Gel Stent, of Preserflo MicroShunt * Previous trabeculectomy and/or minimally invasive glaucoma surgery within the past 6 months * AC intraocular lens * Presence of nanophthalmos, uncontrolled uveitis, silicone oil, Sturge-Weber syndrome or other conditions associated with elevated episcleral venous pressure * Unwilling or unable to give consent, unwilling to accept randomization, or unable to return for scheduled protocol visits * No light perception vision in the study eye or fellow eye visual acuity \< 20/200 * Need for glaucoma surgery combined with other ocular procedures (i.e. corneal transplant, or retinal surgery) or anticipated need for additional ocular surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Central endothelial cell loss (ECL) from baseline | Baseline to 12 months | Change in central endothelial cell density based on assessment of Specular Microscopy images. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraocular Pressure (IOP) at 12 months | 12 months after GDD implantation | Goldman applanation tonometry (preferred method) |
| ECD at 12 months after GDD implantation | 12 months after GDD implantation | ECD measures will be based on the assessment of Specular Microscopy images |
| Best-corrected visual acuity (BCVA) at 12 months after GDD implantation | 12 months after GDD implantation | Distance BCVA using an ETDRS eye chart and recorded as number of letters read correctly. |
| Number of anti-glaucoma medications at 12 months after GDD implantation | 12 months after GDD implantation | Topical and oral anti-glaucoma medication information is collected at all visits. |
Countries
Canada, United States
Contacts
CONTACTGui-shuang Ying, PhD
STUDY_CHAIRYing Han, MD, PhD
University of California, San Francisco
STUDY_DIRECTORJennifer Rose-Nussbaumer, MD
Stanford University
STUDY_DIRECTORThuy Doan, MD, PhD
University of California San Fransicso
Outcome results
None listed