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The Baerveldt Versus ClearPath Comparison Study

NCT04468633 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2024-09-05

Study results available
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Summary

This is a randomized prospective study of post-operative surgical outcomes and complication rates in patients with a Baerveldt 350 implant vs the Ahmed ClearPath implant. Each subject will be randomized to the Baerveldt group or ClearPath group at the time of consent for the study.

Conditions

Interventions

DEVICE

Baerveldt 350 implant

The Baerveldt implant is an FDA-approved silicone, non-valved implant.

DEVICE

Ahmed ClearPath 350 implant

The Ahmed ClearPath is a non-valved glaucoma drainage device.

Sponsors & Collaborators

Principal Investigators

  • Leon Herndon, MD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-17
Primary Completion
2023-06-29
Completion
2023-06-29
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04468633 on ClinicalTrials.gov