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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2015-11-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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IOL placement with Hydrus Implant

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

Group Type EXPERIMENTAL

Hydrus Implant

Intervention Type DEVICE

IOL placement only.

Cataract Extraction with IOL placement only.

Group Type ACTIVE_COMPARATOR

IOL placement

Intervention Type PROCEDURE

Interventions

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Hydrus Implant

Intervention Type DEVICE

IOL placement

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No