Baerveldt 350 vs Ahmed ClearPath 250 for the Treatment of Glaucoma

NCT04542616 | Completed Results FDA Device

• 1 other identifier: STUDY00004680
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Glaucoma

Keywords

Glaucoma; Baerveldt 350; Ahmed ClearPath 250

Outcome Measures

Primary Outcomes (1)

• Intraocular Pressure (IOP)

  Mean IOP in each treatment group at the above time points

  Baseline, Month 1, Month 3, Month 6, Month 12, Month 24

Study Arms (2)

Baerveldt 350

ACTIVE COMPARATOR

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

Ahmed ClearPath 250

ACTIVE COMPARATOR

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

Interventions

Baerveldt 350 vs. Ahmed ClearPath 250 tube shunt implantation DEVICE

Baerveldt 350 vs. Ahmed ClearPath 250 tube shunt implantation for the treatment of severe uncontrolled glaucoma.

Ahmed ClearPath 250; Baerveldt 350

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• State University of New York at Buffalo: lead

Study Sites (1)

The Ira G. Ross Eye Institute

Buffalo, New York, 14209, United States

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Results Point of Contact

• Title: Asher Weiner
• Organization: University at Buffalo

aweiner7@gmail.com

(716) 888-4760

Study Officials

• Asher Weiner, MD

  The Ross Eye Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All patients will sign a consent form indicating they will be randomly receiving one of the 2 tube shunt models. It would be impossible to mask the patient or care provider to the type of tube shunt a patient received. The patients cannot bias the clinical data recorded on their follow up exams. All data will be recorded objectively. The outcome assessor will be masked to the type of shunt used.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Model Details: Comparison between 2 groups of patients requiring tube shunt implantation to treat their severe uncontrolled glaucoma. One group will receive a unilateral Baerveldt 350 tube shunt and the other a unilateral Ahmed ClearPath 250 tube shunt. The patients will be sequentially randomized into one of these tube shunts.

Study Record Dates

• First Submitted: August 27, 2020
• First Posted: September 9, 2020
• Study Start: August 13, 2020
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: April 17, 2026
• Results First Posted: April 17, 2026

Record last verified: 2025-01

Locations

US (1)