The Baerveldt Versus ClearPath Comparison Study
Completed · Not applicable
Conditions studied: Glaucoma
In brief
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.
Key facts
- Study ID
- NCT04468633
- Run by
- Duke University
- People needed
- 76
- Starts
- 2020-12-17
- Expected to finish
- 2023-06-29
- Last updated by the study team
- 2024-09-05
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Duke Eye Center — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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