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

November 13, 2023 updated by: Transcend Medical, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

172

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Neubrandenburg, Germany
        • Klinik for Augenheilkunde - Dietrich Bonhoeffer Klinikum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects with OAG who underwent combination cataract/glaucoma surgery and received the CyPass Micro-Stent using the CyPass Applier Model 241

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ocular adverse events in the study eye
Time Frame: Intraoperatively though the first 3 postoperative months
Intraoperatively though the first 3 postoperative months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Transcend Medical, Inc.

Investigators

  • Study Chair: Tsontcho (Sean) Ianchulev, MD, MPH, Transcend Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

August 27, 2014

First Submitted That Met QC Criteria

August 27, 2014

First Posted (Estimated)

August 29, 2014

Study Record Updates

Last Update Posted (Actual)

November 15, 2023

Last Update Submitted That Met QC Criteria

November 13, 2023

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TMI-14-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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