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

Sponsor
Transcend Medical, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02228577
Collaborator
(none)
172
Enrollment
1
Location
2
Duration (Months)
85.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    172 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    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
    Study Start Date :
    Aug 1, 2014
    Actual Primary Completion Date :
    Oct 1, 2014
    Actual Study Completion Date :
    Oct 1, 2014

    Outcome Measures

    Primary Outcome Measures

    1. Ocular adverse events in the study eye [Intraoperatively though the first 3 postoperative months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Klinik for Augenheilkunde - Dietrich Bonhoeffer Klinikum Neubrandenburg Germany

    Sponsors and Collaborators

    • Transcend Medical, Inc.

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Transcend Medical, Inc.
    ClinicalTrials.gov Identifier:
    NCT02228577
    Other Study ID Numbers:
    • TMI-14-01
    First Posted:
    Aug 29, 2014
    Last Update Posted:
    May 16, 2017
    Last Verified:
    Oct 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Glaucoma
    Glaucoma, Open-Angle

    Study Results

    No Results Posted as of May 16, 2017