Completed

Hydrus IIA 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.

What is being tested

Hydrus Implant

+ IOL placement

DeviceProcedure

Who is being recruted

Eye Diseases+1

+ Ocular Hypertension

+ Glaucoma

From 21 to 80 Years

+4 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: January 2011

See protocol details

Summary

Principal SponsorIvantis, Inc.

Last updated: February 4, 2019

Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2011

Actual date on which the first participant was enrolled.

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.

NCT01818115

Principal SponsorIvantis, Inc.

Last updated: February 4, 2019

Sourced from a government-validated database.Claim as a partner

Protocol

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

Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 21 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Eye DiseasesOcular HypertensionGlaucomaGlaucoma, Open-Angle

Criteria

2 inclusion criteria required to participate

Diagnosis of Primary Open Angle Glaucoma or Pseudoexfoliative Glaucoma

Operable, age-related cataract eligible for phacoemulsification

2 exclusion criteria prevent from participating

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

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Cataract extraction with intraocular lens (IOL) placement and Hydrus Implant

Group II

Active Comparator

Cataract Extraction with IOL placement only.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 7 locations

See Central Contact

Frankfurt, GermanyOpen See Central Contact in Google Maps

See Central Contact

Mainz, Germany

See Central Contact

Parma, Italy

See Central Contact

Torino, Italy

Completed7 Study Centers