Glaucoma Drainage Device and Endothelial Cell Loss Compare Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Glaucoma Drainage Device and Endothelial Cell Loss Compare Trial

Conditions
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Glaucoma

Intervention / Treatment
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* Procedure: Sulcus tube placement
* Procedure: Anterior chamber (AC) tube placement


Participation Criteria
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Eligibility Criteria
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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 Previous GDD implantation or Xen Gel Stent or placement of Cypass Micro-stent or 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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).
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sulcus tube placement<br>Glaucoma drainage device (GDD) implantation with tube placement in the ciliary sulcus | Procedure: Sulcus tube placement<br>* GDD implantation surgery with tube placement in the ciliary sulcus<br>|
| Active Comparator: Anterior chamber (AC) tube placement<br>Glaucoma drainage device (GDD) implantation with tube placement in the anterior chamber | Procedure: Anterior chamber (AC) tube placement<br>* GDD implantation surgery with tube placement in the anterior chamber<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central endothelial cell loss (ECL) from baseline | Change in central endothelial cell density based on assessment of Specular Microscopy images. | Baseline to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular Pressure (IOP) at 12 months | Goldman applanation tonometry (preferred method) | 12 months after GDD implantation | 
| ECD at 12 months after GDD implantation | ECD measures will be based on the assessment of Specular Microscopy images | 12 months after GDD implantation | 
| Best-corrected visual acuity (BCVA) at 12 months after GDD implantation | Distance BCVA using an ETDRS eye chart and recorded as number of letters read correctly. | 12 months after GDD implantation | 
| Number of anti-glaucoma medications at 12 months after GDD implantation | Topical and oral anti-glaucoma medication information is collected at all visits. | 12 months after GDD implantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glaucoma, glaucoma drainage device, endothelial cell density, endothelial cell loss, intraocular pressure