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

January 31, 2019 updated by: Ivantis, Inc.

A Prospective, Multi-Center, Randomized Controlled Trial to Evaluate the Safety and Effectiveness of the Hydrus Implant for Lowering Intraocular Pressure in Glaucoma Patients Undergoing Cataract Surgery.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a post-market, prospective, single-masked, randomized, controlled, multicenter clinical trial comparing Cataract Extraction (CE) surgery + Hydrus Implant vs CE surgery alone for the reduction of intraocular pressure (IOP) in patients with a positive diagnosis for open angle glaucoma (POAG) or pseudoexfoliative glaucoma. Eligible patients will be scheduled for cataract surgery. At the time of the procedure, qualified subjects will be randomized into 1 of 2 treatment groups: Hydrus Implant with cataract surgery or cataract surgery alone. Post-operative follow up will be conducted at regular intervals.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Frankfurt, Germany
        • See Central Contact
      • Mainz, Germany
        • See Central Contact
  • Italy
      • Parma, Italy
        • See Central Contact
      • Torino, Italy
        • See Central Contact
  • Netherlands
      • Rotterdam, Netherlands
        • See Central Contact
  • Spain
      • Madrid, Spain
        • See Central Contact
      • Zaragoza, Spain
        • See Central Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of Primary Open Angle Glaucoma or Pseudoexfoliative Glaucoma.
  • Operable, age-related cataract eligible for phacoemulsification.

Exclusion Criteria:

  • Closed Angle and narrow angle forms of Glaucoma.
  • Other Secondary Glaucoma, (such as neovascular, uveitic, traumatic, steroid induced, lens induced); glaucoma associated with increase episcleral venous pressure; congenital or developmental glaucoma.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: IOL placement with Hydrus Implant
Cataract extraction with intraocular lens (IOL) placement and Hydrus Implant
Device: Hydrus Implant
ACTIVE_COMPARATOR: IOL placement only.
Cataract Extraction with IOL placement only.
Procedure: IOL placement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in proportion of subjects with 20% reduction in mean diurnal Intraocular Pressure (IOP) at 24 months following the wash-out of all glaucoma medications.
Time Frame: 24 months
The 24 month diurnal IOP will be compared to the baseline value and a % change will be determined for each subject. A 20% drop in diurnal IOP is a successful response to treatment.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in mean washed out IOP at 24 months
Time Frame: 24 months
The mean diurnal IOP for each subject will be calculated and the sorted by group. The group average IOP will be compared to in-group baseline and between groups at the follow up time point.
24 months
Change in Best-corrected Visual Acuity (BCVA) from baseline to 12 months as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart.
Time Frame: 12 months
A 24 month visit will be conducted to confirm 12 month findings.
12 months
The proportion of eyes with IOP >5 mmHg to ≤19 mmHg following terminal washout.
Time Frame: 12 months
A 24 month visit will be conducted to confirm 12 month findings.
12 months
Diurnal IOP at 12 months following washout
Time Frame: 12 months
A 24 month visit will be conducted to confirm 12 month findings
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ivantis, Inc.

Investigators

  • Principal Investigator: Prof. Norbert Pfeiffer, MD, Universitätsmedizin Mainz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (ACTUAL)

August 1, 2015

Study Completion (ACTUAL)

November 1, 2015

Study Registration Dates

First Submitted

February 29, 2012

First Submitted That Met QC Criteria

March 25, 2013

First Posted (ESTIMATE)

March 26, 2013

Study Record Updates

Last Update Posted (ACTUAL)

February 4, 2019

Last Update Submitted That Met QC Criteria

January 31, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP-10-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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