Status:
COMPLETED
The Baerveldt Versus ClearPath Comparison Study
Lead Sponsor:
Duke University
Conditions:
Glaucoma
Eligibility:
All Genders
18-90 years
Phase:
NA
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 randomiz...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 29 2023
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT04468633
Start Date
December 17 2020
End Date
June 29 2023
Last Update
September 5 2024
Active Locations (1)
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1
Duke Eye Center
Durham, North Carolina, United States, 27705