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Safety and Efficacy Trial to Evaluate the Hydrus(TM) Implant in Subjects Undergoing Cataract Surgery.

NCT01818115 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2019-02-04

No results posted yet for this study

Summary

The objective of this study is to demonstrate the ability of the Hydrus Implant to lower intraocular pressure in glaucoma patients undergoing cataract surgery.

Conditions

  • Primary Open Angle Glaucoma
  • Glaucoma, Open Angle, Pseudo-exfoliative
  • Cataract Unilateral Pending Extraction

Interventions

DEVICE

Hydrus Implant

PROCEDURE

IOL placement

Sponsors & Collaborators

  • Ivantis, Inc.

    lead INDUSTRY

Principal Investigators

  • Prof. Norbert Pfeiffer, MD · Universitatsmedizin Mainz

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2015-08-31
Completion
2015-11-30

Countries

  • Germany
  • Italy
  • Netherlands
  • Spain

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 NCT01818115 on ClinicalTrials.gov