North Bay Eye Associates | Petaluma, CA
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A Randomized Clinical Trial of Ab Interno Canaloplasty and Trabeculotomy with the OMNI® Surgical System Compared to Standard Medical Treatment in Pseudophakic Patients with Primary Open Angle Glaucoma (EVOLVE)
Full description
This prospective, multicenter, post-market clinical trial will evaluate the safety and effectiveness of canaloplasty and trabeculotomy using the OSS in pseudophakic patients with POAG with DIOP ≥ 20 mmHg on prostaglandin monotherapy.
Enrollment
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Inclusion criteria
Exclusion criteria
Any of the following prior ocular procedures:
Concurrent IOP-lowering procedure other than the study procedure (OSS) (e.g. ECP, CPC,etc.)
Forms of glaucoma other than POAG including but not limited to: Pigmentary, pseudoexfoliative, acute angle closure, normal tension, pre-perimetric, traumatic, congenital, malignant, uveitic, neovascular or severe glaucoma as documented in subject's medical record.
Women of childbearing potential if they are currently pregnant or intend to become pregnant during the study period; are breast-feeding; or are not in agreement to use adequate birth control methods to prevent pregnancy throughout the study
Primary purpose
Allocation
Interventional model
Masking
334 participants in 2 patient groups
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Central trial contact
Afua Ohene-Nyako, MS; Jaime Dickerson, PhD
Data sourced from clinicaltrials.gov
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