Safety and Performance Study of the CyPass System Applier Model 241

A Study Assessing the Safety and Performance of the Transcend CyPass System Applier Model 241 for Implantation of the CyPass Micro-Stent in Subjects With Open Angle Glaucoma Who Underwent Cataract Surgery

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02228577

Acronym

RePASS

Enrollment

172

Registered

2014-08-29

Start date

2014-08-31

Completion date

2014-10-31

Last updated

2023-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Open Angle Glaucoma (OAG)

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Ocular adverse events in the study eye	Intraoperatively though the first 3 postoperative months

Countries

Germany

Outcome results