Safety and Performance Study of the CyPass System Applier Model 241 (RePASS)

Transcend Medical

Status: Completed

Conditions: Open Angle Glaucoma (OAG)

Study type: Observational

Funder types: Industry

Identifiers

NCT02228577

TMI-14-01

Details and patient eligibility

About

This is a retrospective chart review of cases in which the CyPass Micro-Stent was implanted using the Model 241 Applier. The objective of this study is to characterize and evaluate the safety of the Model 241 Applier when used for CyPass Micro-Stent implantation.

Enrollment: 172 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosis of OAG
2. CyPass Micro-Stent implantation (using the CyPass system 241) following uncomplicated phacoemulsification cataract removal and intraocular lens implantation

Exclusion criteria

1. Diagnosis of acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma
2. Prior incisional glaucoma surgery