Baerveldt 350 vs Ahmed ClearPath 250 for the Treatment of Glaucoma (B350vsCP250)

Outcomes Comparison Between Baerveldt 350 and Ahmed ClearPath 250 Tube Shunts for the Treatment of Glaucoma

To compare the safety and efficacy of Baerveldt 350 and Ahmed ClearPath 250 tube shunts in lowering IOP in glaucoma patients.

Study Overview

• Status: Recruiting
• Conditions: Glaucoma
• Intervention / Treatment: Device: Baerveldt 350 vs. Ahmed ClearPath 250 tube shunt implantation

Detailed Description

Tube shunt implantation is a common type of surgery considered standard of care for treating significant potentially-blinding glaucoma where medical and laser treatment, and previous surgeries, have failed to control intra-ocular pressure (IOP) sufficiently to stop glaucoma progression towards blindness.

Since a larger plate tube (e.g., Baerveldt 350) is more difficult to implant requiring longer surgical time and intraoperative ocular muscle manipulation with possible patient discomfort, a smaller plate tube shunt (e.g., Ahmed ClearPath 250) requiring shorter surgical time and no ocular muscle manipulation may have an advantage if the long term surgical outcomes were the same.

However, the literature is lacking regarding the effect of the tube plate size on the final outcomes of tube shunt implantation. Most published comparisons are between totally different types of tube shunts regardless of plate size, often made of different materials, often comparing valved vs. non-valved tube shunts,combining different plate sizes in the same study groups,5 mixing tubes with or without combined cataract surgery in the same study groups, or comparing surgeries performed by several surgeons utilizing different surgical methods. Further, all these studies utilize tubes implanted into the anterior chamber (AC) thus increasing the risk of corneal failure, with no comparisons at all between tube shunts implanted through the ciliary sulcus of the eye designed to reduce the risk of corneal failure. Our Principle Investigator (AW) is specializing and well-published in this type of tube shunt implantation.

This prospective randomized trial is designed to resolve all these confusing factors in the literature and finally provide the answer of whether tube plate size has an effect on the final outcomes of tube shunt implantation by performing a "clean" study that would isolate the effect of tube plate size on long term outcomes. To achieve this goal our study will utilize two non-valved tube shunts with a different plate size (350 vs. 250 mm2) made of identical materials, in eyes that have already had cataract surgery, and all performed by the same surgeon (AW) through the ciliary sulcus.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Asher Weiner, MD; Phone Number: 716-881-7900; Email: asherwei@buffalo.edu
• Study Contact Backup: Name: Sharon Michalovic, BA; Phone Number: 716-881-7975; Email: sab1@buffalo.edu

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14209
      • Recruiting
      • The Ira G. Ross Eye Institute
      • Contact: Sharon Michalovic; Phone Number: 716-881-7975; Email: sab1@buffalo.edu
      • Contact: Asher Weiner, MD; Phone Number: 7168817900; Email: asherwei@buffalo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.
• Pseudophakia
• Patients who are willing to participate and are able to understand and sign the study consent form.
• Age ≥18 years.

Exclusion Criteria:

• Phakic eyes (no previous cataract surgery).
• Aphakic eyes (status post previous cataract removal but without a lens implant).
• Age <18 years.
• Women of child-bearing age.
• Patients unable to comprehend and sign the study consent form.
• Women who are pregnant.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Baerveldt 350; The patients in this arm will receive a Baerveldt 350 tube shunt implantation for the treatment of their severe uncontrolled glaucoma.	Device: Baerveldt 350 vs. Ahmed ClearPath 250 tube shunt implantation; Baerveldt 350 vs. Ahmed ClearPath 250 tube shunt implantation for the treatment of severe uncontrolled glaucoma.
Active Comparator: Ahmed ClearPath 250; The patients in this arm will receive an Ahmed ClearPath 250 tube shunt implantation for the treatment of their severe uncontrolled glaucoma.	Device: Baerveldt 350 vs. Ahmed ClearPath 250 tube shunt implantation; Baerveldt 350 vs. Ahmed ClearPath 250 tube shunt implantation for the treatment of severe uncontrolled glaucoma.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in intraocular pressure	Change in Intraocular pressure between preoperative baseline and postoperative follow-up visits	2 years

Collaborators and Investigators

• Sponsor: State University of New York at Buffalo
• Investigators: Principal Investigator: Asher Weiner, MD, The Ross Eye Institute

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2020
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): August 31, 2025

Study Registration Dates

• First Submitted: August 27, 2020
• First Submitted That Met QC Criteria: September 2, 2020
• First Posted (Actual): September 9, 2020

Study Record Updates

• Last Update Posted (Actual): October 12, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Glaucoma; Baerveldt 350; Ahmed ClearPath 250
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: STUDY00004680

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes