Safety and Performance Study of the CyPass System Applier Model 241

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.

Completed

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Key information

Conditions

Open Angle Glaucoma (OAG) Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinik for Augenheilkunde - Dietrich Bonhoeffer Klinikum

Neubrandenburg, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

Ocular adverse events in the study eye

Time frame: Intraoperatively though the first 3 postoperative months

Sponsors and collaborators

Lead sponsor

Transcend Medical, Inc.

Industry

Registry information

Official study 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

Acronym: RePASS

Important dates

Study start: 2014
Primary completion: 2014
Study completion: 2014
First posted: Aug 29, 2014
Registry last updated: Nov 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed