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

Ivantis, Inc.100 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

100

Conditions

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

Interventions

Hydrus ImplantDEVICE

IOL placementPROCEDURE

Eligibility

Sex: ALLMin age: 21 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (7)

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Frankfurt, Germany

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Mainz, Germany

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Parma, Italy

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Torino, Italy

Outcomes

Primary Outcomes

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.

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.

Time frame: 24 months

Secondary Outcomes

Reduction in mean washed out IOP at 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.

Time frame: 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.

A 24 month visit will be conducted to confirm 12 month findings.

Time frame: 12 months

The proportion of eyes with IOP >5 mmHg to ≤19 mmHg following terminal washout.

A 24 month visit will be conducted to confirm 12 month findings.

Time frame: 12 months

Diurnal IOP at 12 months following washout

A 24 month visit will be conducted to confirm 12 month findings

Time frame: 12 months

Data from ClinicalTrials.gov

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