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

Not Applicable

Completed

• Conditions: Cataract Unilateral Pending Extraction; Glaucoma, Open Angle, Pseudo-exfoliative; Primary Open Angle Glaucoma
• Interventions: Procedure: IOL placement; Device: Hydrus Implant

• Registration Number: NCT01818115
• Lead Sponsor: Ivantis, Inc.

Brief 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.

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 Timeline

• Study Start: 2011-01
• Study First Submitted: 2012-02-29
• Study First Submitted QC: 2013-03-25
• Study First Posted: 2013-03-26
• Primary Completion: 2015-08
• Study Completion: 2015-11
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-31
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IOL placement only.	IOL placement	Cataract Extraction with IOL placement only.
IOL placement with Hydrus Implant	Hydrus Implant	Cataract extraction with intraocular lens (IOL) placement and Hydrus Implant

Primary Outcome Measures

Name	Time	Method
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.	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.

Secondary Outcome Measures

Name	Time	Method
The proportion of eyes with IOP >5 mmHg to ≤19 mmHg following terminal washout.	12 months	A 24 month visit will be conducted to confirm 12 month findings.
Reduction in mean washed out IOP at 24 months	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.
Change in Best-corrected Visual Acuity (BCVA) from baseline to 12 months as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart.	12 months	A 24 month visit will be conducted to confirm 12 month findings.
Diurnal IOP at 12 months following washout	12 months	A 24 month visit will be conducted to confirm 12 month findings

Trial Locations

Locations (1)

See Central Contact; 🇪🇸 Zaragoza, Spain