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

Primary Open Angle Glaucoma Clinical Trial

— Hydrus II  

Official title:

A 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01818115
• Other study ID #: CP-10-001
• Status: Completed
• Phase: N/A
• Start date: January 2011
• Est. completion date: November 2015

Study information

• Verified date: January 2019
• Source: Ivantis, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Device:
• Hydrus Implant

Procedure:
• IOL placement

Locations

Country	Name	City	State
Germany	See Central Contact	Frankfurt
Germany	See Central Contact	Mainz
Italy	See Central Contact	Parma
Italy	See Central Contact	Torino
Netherlands	See Central Contact	Rotterdam
Spain	See Central Contact	Madrid
Spain	See Central Contact	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Ivantis, Inc.

Countries where clinical trial is conducted

Germany,  Italy,  Netherlands,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 months
Secondary	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.	24 months
Secondary	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.	12 months
Secondary	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.	12 months
Secondary	Diurnal IOP at 12 months following washout	A 24 month visit will be conducted to confirm 12 month findings	12 months