The Baerveldt Versus ClearPath Comparison Study

Duke University76 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Glaucoma

Interventions

Baerveldt 350 implantDEVICE

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

Ahmed ClearPath 350 implantDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Locations (1)

Duke Eye Center

Durham, North Carolina, United States

Outcomes

Primary Outcomes

Intraocular Pressure (IOP)

Time frame: Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1

Number of Participants Who Experienced a Complication

Time frame: Up to Year 1

Secondary Outcomes

Best Corrected Visual Acuity (BCVA)

Time frame: 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)

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline and Year 1

Data from ClinicalTrials.gov

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