N/A Completed N=76 Randomized Single-blind Treatment

The Baerveldt Versus ClearPath Comparison Study

Glaucoma

Source: ClinicalTrials.gov NCT04468633 ↗

Enrolled (actual)

Serious AEs

1.3%

Results posted

Sep 2024

Primary outcomePrimary: Intraocular Pressure (IOP) — 21.7; 22.4; 14.9; 12.6 mmHg — p=0.687

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Intraocular Pressure (IOP)	21.7; 22.4; 14.9; 12.6; 10.7; 11.5	0.687
PRIMARY Number of Participants Who Experienced a Complication	13; 4	—
SECONDARY Best Corrected Visual Acuity (BCVA)	0.40; 0.56; 0.71; 1.09; 0.65; 1.03	—
SECONDARY Number of Individual Eyedrop Medications That the Patient is on (Prescribed and Actually Taking)	2.7; 2.7; 0.6; 0.7; 0.8; 0.9	—
SECONDARY Change in Humphrey Visual Field (HVF)	2.81; 4.72	0.759
SECONDARY Change in Thickness of the Cornea as Measured by Pachymetry	12.18; 25.96	0.603
SECONDARY Change in Retinal Nerve Fiber Layer (RNFL)	2.81; 4.72	0.833

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04468633). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.