The Baerveldt Versus ClearPath Comparison Study

Not Applicable

Completed

• Conditions: Glaucoma
• Interventions: Device: Baerveldt 350 implant; Device: Ahmed ClearPath 350 implant

• Registration Number: NCT04468633
• Lead Sponsor: Duke University

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-07-09
• Study First Submitted QC: 2020-07-09
• Study First Posted: 2020-07-13
• Study Start: 2020-12-17
• Primary Completion: 2023-06-29
• Study Completion: 2023-06-29
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-03
• Last Update Posted: 2023-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Baerveldt 350 implant	Baerveldt 350 implant	-
Ahmed ClearPath 350 implant	Ahmed ClearPath 350 implant	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)	Baseline and Year 1	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.
Change in Thickness of the Cornea as Measured by Pachymetry	Baseline and Year 1	Pachymetry is an ophthalmological test that measures the thickness of the cornea.
Change in Retinal Nerve Fiber Layer (RNFL)	Baseline and Year 1	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.

Trial Locations

Locations (1)

Duke Eye Center; 🇺🇸 Durham, North Carolina, United States