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Tube Shunt

Tube Shunt Implantation for Glaucoma (B350vsCP250 Trial)

N/A
Recruiting
Led By Asher Weiner, MD
Research Sponsored by State University of New York at Buffalo
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Significant uncontrolled glaucoma despite medical, laser or previous surgical therapy that requires tube shunt implantation as standard-of-care to stabilize the glaucoma and preserve vision.
Age ≥18 years.
Must not have
Patients unable to comprehend and sign the study consent form.
Women who are pregnant.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial compares the safety and efficacy of two different types of tube shunts in lowering IOP in glaucoma patients.

Who is the study for?
This trial is for adults over 18 with advanced glaucoma not controlled by medication, laser, or previous surgery. They must understand and agree to the study's process. It excludes women who can have children, pregnant women, those under 18, and patients without a lens implant after cataract removal.
What is being tested?
The trial compares two devices designed to lower eye pressure in glaucoma: Baerveldt 350 and Ahmed ClearPath 250 tube shunts. The goal is to see which one is safer and more effective at preserving vision in patients with severe glaucoma.
What are the potential side effects?
Potential side effects from the tube shunt implantation may include discomfort or pain at the surgical site, infection risk, changes in vision, bleeding inside the eye (hyphema), low eye pressure (hypotony), or scarring around the device.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have severe glaucoma not managed by current treatments, needing a tube shunt.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am able to understand and sign the study consent form.
Select...
I am currently pregnant.
Select...
I am under 18 years old.
Select...
I have had cataract surgery but do not have a lens implant.
Select...
I have not had cataract surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in intraocular pressure

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: Baerveldt 350Active Control1 Intervention
The patients in this arm will receive a Baerveldt 350 tube shunt implantation for the treatment of their severe uncontrolled glaucoma.
Group II: Ahmed ClearPath 250Active Control1 Intervention
The patients in this arm will receive an Ahmed ClearPath 250 tube shunt implantation for the treatment of their severe uncontrolled glaucoma.

Find a Location

Who is running the clinical trial?

State University of New York at BuffaloLead Sponsor
268 Previous Clinical Trials
51,540 Total Patients Enrolled
3 Trials studying Glaucoma
386 Patients Enrolled for Glaucoma
Asher Weiner, MD4.612 ReviewsPrincipal Investigator - The Ross Eye Institute
State University of New York at Buffalo
1 Previous Clinical Trials
80 Total Patients Enrolled
1 Trials studying Glaucoma
80 Patients Enrolled for Glaucoma
5Patient Review
This doctor is very skilled and compassionate.

Media Library

Ahmed ClearPath 250 (Tube Shunt) Clinical Trial Eligibility Overview. Trial Name: NCT04542616 — N/A
Glaucoma Research Study Groups: Baerveldt 350, Ahmed ClearPath 250
Glaucoma Clinical Trial 2023: Ahmed ClearPath 250 Highlights & Side Effects. Trial Name: NCT04542616 — N/A
Ahmed ClearPath 250 (Tube Shunt) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04542616 — N/A
~13 spots leftby Dec 2025
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