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A Study to Assess Long-Term Safety of the CyPass Micro-Stent in Patients Completing the COMPASS Trial

NCT02700984 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 282

Last updated 2024-01-24

Study results available
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Summary

The purpose of this study is to evaluate the long-term safety of the CyPass Micro-Stent in subjects who completed Study Protocol TMI-09-01, COMPASS Trial.

Conditions

  • Primary Open Angle Glaucoma (POAG)

Interventions

DEVICE

CyPass Micro-Stent

The CyPass Micro-Stent is a small tube with a through-lumen designed to redirect aqueous fluid from the front into the back of the eye. The device is implanted after completion of cataract surgery.

PROCEDURE

Cataract Surgery

Cataract surgery involves the removal of the natural lens, which has become clouded (called a cataract), and insertion of an artificial lens (called an intraocular lens). This procedure is done through a small surgical incision in the eye.

Sponsors & Collaborators

  • Transcend Medical, Inc.

    collaborator INDUSTRY

  • Alcon Research

    lead INDUSTRY

Principal Investigators

  • Alcon, Research · Alcon Research

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-30
Primary Completion
2018-04-18
Completion
2018-04-18
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02700984 on ClinicalTrials.gov