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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02228577
Recruitment Status : Completed
First Posted : August 29, 2014
Last Update Posted : May 16, 2017
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( 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.

Condition or disease
Open Angle Glaucoma (OAG)

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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 : August 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma




Primary Outcome Measures :
  1. Ocular adverse events in the study eye [ Time Frame: Intraoperatively though the first 3 postoperative months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02228577


Locations
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Germany
Klinik for Augenheilkunde - Dietrich Bonhoeffer Klinikum
Neubrandenburg, Germany
Sponsors and Collaborators
Transcend Medical, Inc.
Investigators
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Study Chair: Tsontcho (Sean) Ianchulev, MD, MPH Transcend Medical

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Responsible Party: Transcend Medical, Inc.
ClinicalTrials.gov Identifier: NCT02228577    
Other Study ID Numbers: TMI-14-01
First Posted: August 29, 2014    Key Record Dates
Last Update Posted: May 16, 2017
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases