Study Results
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View full resultsBasic Information
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COMPLETED
NA
76 participants
INTERVENTIONAL
2020-12-17
2023-06-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Baerveldt 350 implant
Baerveldt 350 implant
The Baerveldt implant is an FDA-approved silicone, non-valved implant.
Ahmed ClearPath 350 implant
Ahmed ClearPath 350 implant
The Ahmed ClearPath is a non-valved glaucoma drainage device.
Interventions
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Baerveldt 350 implant
The Baerveldt implant is an FDA-approved silicone, non-valved implant.
Ahmed ClearPath 350 implant
The Ahmed ClearPath is a non-valved glaucoma drainage device.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
90 Years
ALL
No
Sponsors
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Duke University
OTHER
Responsible Party
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Principal Investigators
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Leon Herndon, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Duke Eye Center
Durham, North Carolina, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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PRO00105781
Identifier Type: -
Identifier Source: org_study_id
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