The Baerveldt Versus ClearPath Comparison Study

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.

Study Overview

• Status: Completed
• Conditions: Glaucoma
• Intervention / Treatment: Device: Baerveldt 350 implant; Device: Ahmed ClearPath 350 implant

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke Eye Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Men or women with age at screening ≥ 18 years and ≤ 90 years
• Inadequately controlled glaucoma
• Valve-less aqueous shunt as the planned surgical procedure
• Patients with primary glaucomas or pseudoexfoliation, pigmentary and traumatic glaucoma with a previous failed trabeculectomy or other intraocular surgery included.
• Primary tubes included
• Investigators to recruit consecutively all eligible patients from their clinics.
• Superotemporal or inferonasal placement of the tube
• Capable and willing to provide consent

Exclusion Criteria:

• NLP
• Unable/unwilling to provide informed consent
• Unavailable for regular follow up
• Previous cyclodestructive procedure
• Prior scleral buckling procedure or other external impediment to supratemporal drainage device implantation
• Presence of silicone oil
• Vitreous in the anterior chamber sufficient to require a vitrectomy
• Uveitic glaucoma
• Neovascular glaucoma
• Nanophthalmos
• Sturge-Weber syndrome or other conditions associated with elevated episcleral venous pressure
• Procedure combined with other surgery
• Any abnormality other than glaucoma in the study eye that could affect tonometry.

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 implant	Device: Baerveldt 350 implant; The Baerveldt implant is an FDA-approved silicone, non-valved implant.
Active Comparator: Ahmed ClearPath 350 implant	Device: Ahmed ClearPath 350 implant; The Ahmed ClearPath is a non-valved glaucoma drainage device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Intraocular Pressure (IOP)	Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1
Number of Participants Who Experienced a Complication	Up to Year 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best Corrected Visual Acuity (BCVA)		Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1
Number of Individual Eyedrop Medications That the Patient is on (Prescribed and Actually Taking)		Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1
Change in Humphrey Visual Field (HVF)	The Humphrey visual field test measures the entire area of peripheral vision that can be seen while the eye is focused on a central point. A positive value indicates an increase in visual field while a negative value indicates a decrease.	Baseline and Year 1
Change in Thickness of the Cornea as Measured by Pachymetry	Pachymetry is an ophthalmological test that measures the thickness of the cornea.	Baseline and Year 1
Change in Retinal Nerve Fiber Layer (RNFL)	The retinal nerve fiber layer (RNFL) is formed by retinal ganglion cell axons, which collect the visual impulses that begin with the rods and cones.	Baseline and Year 1

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life, as Measured by Glaucoma Related Quality of Life 15 Questionnaire		Year 1
Quality of Life, as Measured by Glaucoma Symptom Scale		Year 1
Quality of Life, as Measured by Glaucoma Utility Index		Year 1
Change in Self-report Dysesthesia Scale Questionnaire		Baseline and Year 1
Change in Motility Exam (Hess Screen Test)	If patient is binocular	Baseline and Year 1
Change in Motility Exam (Worth 4-dot)	If patient is binocular	Baseline and Year 1
Change in Motility Exam (Stereo Test)	If patient is binocular	Baseline and Year 1
Change in Motility Exam (9 Gaze Photos)		Baseline and Year 1

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Leon Herndon, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2020
• Primary Completion (Actual): June 29, 2023
• Study Completion (Actual): June 29, 2023

Study Registration Dates

• First Submitted: July 9, 2020
• First Submitted That Met QC Criteria: July 9, 2020
• First Posted (Actual): July 13, 2020

Study Record Updates

• Last Update Posted (Estimated): September 5, 2024
• Last Update Submitted That Met QC Criteria: August 30, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Baerveldt 350 implant; Ahmed ClearPath implant
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: PRO00105781

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No