Safety and Performance Study of the CyPass System Applier Model 241

Open Angle Glaucoma (OAG) Clinical Trial

— RePASS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02228577
• Other study ID #: TMI-14-01
• Status: Completed
• Start date: August 2014
• Est. completion date: October 2014

Study information

• Verified date: October 2016
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Open Angle Glaucoma (OAG)

Locations

Country	Name	City	State
Germany	Klinik for Augenheilkunde - Dietrich Bonhoeffer Klinikum	Neubrandenburg

Sponsors (1)

Lead Sponsor	Collaborator
Transcend Medical, Inc.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular adverse events in the study eye		Intraoperatively though the first 3 postoperative months