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Procedure

Glaucoma Drainage Techniques for Glaucoma (DECLARE Trial)

N/A
Recruiting
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 24 months
Awards & highlights
No Placebo-Only Group

Summary

This trial compares two techniques to reduce cell loss in the eye, which can help with glaucoma.

Who is the study for?
This trial is for adults over 18 with medically uncontrolled glaucoma needing a Glaucoma Drainage Device (GDD) or GDD with phacoemulsification. Candidates must be suitable for GDD implantation in the ciliary sulcus and anterior chamber, able to consent, accept randomization, and attend scheduled visits.
What is being tested?
The DECLARE study compares two ways of placing a glaucoma drainage device: either in the front part of the eye (anterior chamber) or between the iris and front chamber (sulcus). The goal is to see which method better minimizes cell loss in the eye.
What are the potential side effects?
Potential side effects may include changes to vision, discomfort or pain at the site where the device is implanted, increased risk of infection, inflammation inside the eye, and possible damage to cells lining the cornea.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Best-corrected visual acuity (BCVA) at 12 months after GDD implantation
ECD at 12 months after GDD implantation
Intraocular Pressure (IOP) at 12 months
+1 more
Other study objectives
Best-corrected visual acuity (BCVA) at 24 months after GDD implantation
Central endothelial cell loss (ECL) from baseline
ECD at 24 months after GDD implantation
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Anterior chamber (AC) tube placementActive Control1 Intervention
Glaucoma drainage device (GDD) implantation with tube placement in the anterior chamber
Group II: Sulcus tube placementActive Control1 Intervention
Glaucoma drainage device (GDD) implantation with tube placement in the ciliary sulcus

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,079 Previous Clinical Trials
42,721,173 Total Patients Enrolled
1 Trials studying Glaucoma
700 Patients Enrolled for Glaucoma
Stanford UniversityOTHER
2,474 Previous Clinical Trials
17,501,714 Total Patients Enrolled
13 Trials studying Glaucoma
427 Patients Enrolled for Glaucoma
National Eye Institute (NEI)NIH
555 Previous Clinical Trials
1,407,166 Total Patients Enrolled
42 Trials studying Glaucoma
16,888 Patients Enrolled for Glaucoma

Media Library

Anterior chamber (AC) tube placement (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05924477 — N/A
Glaucoma Research Study Groups: Anterior chamber (AC) tube placement, Sulcus tube placement
Glaucoma Clinical Trial 2023: Anterior chamber (AC) tube placement Highlights & Side Effects. Trial Name: NCT05924477 — N/A
Anterior chamber (AC) tube placement (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05924477 — N/A
~136 spots leftby Dec 2026
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