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

Ivantis

Status

Completed

Conditions

Primary Open Angle Glaucoma

Glaucoma, Open Angle, Pseudo-exfoliative

Cataract Unilateral Pending Extraction

Treatments

Procedure: IOL placement

Device: Hydrus Implant

Study type

Interventional

Funder types

Industry

Identifiers

NCT01818115

CP-10-001

Details and patient eligibility

About

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

Full 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.

Enrollment

100 patients

Sex

All

Ages

21 to 80 years old

Volunteers

No Healthy Volunteers

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.