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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
B350vsCP250 Trial 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.Check my eligibility
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.See study design
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.
B350vsCP250 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have severe glaucoma not managed by current treatments, needing a tube shunt.
Select...
I am 18 years old or older.
B350vsCP250 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in intraocular pressure
B350vsCP250 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
246 Previous Clinical Trials
49,438 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had cataract surgery and now have an artificial lens in your eye.I have severe glaucoma not managed by current treatments, needing a tube shunt.I am able to understand and sign the study consent form.I am a woman who could potentially become pregnant.I am currently pregnant.I am 18 years old or older.I am under 18 years old.I have had cataract surgery but do not have a lens implant.I have not had cataract surgery.I am willing and able to sign the study consent form.
Research Study Groups:
This trial has the following groups:- Group 1: Baerveldt 350
- Group 2: Ahmed ClearPath 250
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is participation in this experiment available to individuals right now?
"According to the information on clinicaltrials.gov, this research endeavour is actively seeking participants; it was initially posted in August of 2020 and most recently updated in September 2021."
Answered by AI
What is the enrollment capacity of this research initiative?
"Affirmative. Clinicaltrials.gov reveals that the medical trial is presently looking to recruit 70 individuals from a single site, with initial data posted on August 13th 2020 and most recent updates being made on September 26th 2021."
Answered by AI
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