Safety and Performance Study of the CyPass System Applier Model 241

Completed

• Conditions: Open Angle Glaucoma (OAG)

• Registration Number: NCT02228577
• Lead Sponsor: Transcend Medical, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-08-27
• Study First Submitted QC: 2014-08-27
• Study First Posted: 2014-08-29
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2016-10
• Last Update Submitted: 2023-11-13
• Last Update Posted: 2023-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 172

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ocular adverse events in the study eye	Intraoperatively though the first 3 postoperative months

Trial Locations

Locations (1)

Klinik for Augenheilkunde - Dietrich Bonhoeffer Klinikum; 🇩🇪 Neubrandenburg, Germany