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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

DECLARE Trial 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.Check my eligibility

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.See study design

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.

DECLARE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 24 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

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 outcome measures

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

DECLARE 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor

2,005 Previous Clinical Trials

42,882,061 Total Patients Enrolled

1 Trials studying Glaucoma

700 Patients Enrolled for Glaucoma

Stanford UniversityOTHER

2,395 Previous Clinical Trials

17,341,124 Total Patients Enrolled

12 Trials studying Glaucoma

377 Patients Enrolled for Glaucoma

National Eye Institute (NEI)NIH

547 Previous Clinical Trials

1,401,931 Total Patients Enrolled

41 Trials studying Glaucoma

13,175 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many geographical locations are currently hosting this experiment?

"This trial is recruiting patients from 10 different sites. Some of these centres include the Bascom Palmer Eye Institute in Miami, Massachusetts Eye and Ear in Boston, University of Buffalo/State University of New york in Buffalo, as well as 5 other locations."

Answered by AI

Are there any unfilled slots for participants in this research project?

"Evidently, the research posted on clinicaltrials.gov is not presently seeking volunteers for participation. Firstly advertised on 6/1/2023 and lastly edited on 6/20/2023, this particular study has concluded recruitment; however, there are 189 other trials actively enlisting patients currently."

Answered by AI