MedTrace Logo

Study of an Implantable Device for Lowering Intraocular Pressure in Glaucoma Patients Undergoing Cataract Surgery

NCT01085357 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 897

Last updated 2017-05-15

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to evaluate the safety and efficacy of the CyPass Implant for lowering intraocular pressure (IOP) in patients with glaucoma who undergo cataract surgery.

Conditions

  • Primary Open Angle Glaucoma (POAG)
  • Cataract

Interventions

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.

DEVICE

CyPass Micro-Stent

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

Sponsors & Collaborators

  • Transcend Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Vice President of Medical Affairs · Transcend Medical, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2015-03-31
Completion
2015-03-31

More Related Trials

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 NCT01085357 on ClinicalTrials.gov