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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Hydrus Implant
IOL placement
Sponsored by
Ivantis, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Open Angle Glaucoma focused on measuring POAG, PXG, IOL Surgery, CE Surgery

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • See Central Contact
  • See Central Contact
  • See Central Contact
  • See Central Contact
  • See Central Contact
  • See Central Contact
  • See Central Contact

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IOL placement with Hydrus Implant

IOL placement only.

Arm Description

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

Cataract Extraction with IOL placement only.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
Diurnal IOP at 12 months following washout
A 24 month visit will be conducted to confirm 12 month findings

Full Information

First Posted
February 29, 2012
Last Updated
January 31, 2019
Sponsor
Ivantis, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01818115
Brief Title
Safety and Efficacy Trial to Evaluate the Hydrus(TM) Implant in Subjects Undergoing Cataract Surgery.
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ivantis, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open Angle Glaucoma, Glaucoma, Open Angle, Pseudo-exfoliative, Cataract Unilateral Pending Extraction
Keywords
POAG, PXG, IOL Surgery, CE Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IOL placement with Hydrus Implant
Arm Type
Experimental
Arm Description
Cataract extraction with intraocular lens (IOL) placement and Hydrus Implant
Arm Title
IOL placement only.
Arm Type
Active Comparator
Arm Description
Cataract Extraction with IOL placement only.
Intervention Type
Device
Intervention Name(s)
Hydrus Implant
Intervention Type
Procedure
Intervention Name(s)
IOL placement
Primary Outcome Measure Information:
Title
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.
Description
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 Outcome Measure Information:
Title
Reduction in mean washed out IOP at 24 months
Description
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
Title
Change in Best-corrected Visual Acuity (BCVA) from baseline to 12 months as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart.
Description
A 24 month visit will be conducted to confirm 12 month findings.
Time Frame
12 months
Title
The proportion of eyes with IOP >5 mmHg to ≤19 mmHg following terminal washout.
Description
A 24 month visit will be conducted to confirm 12 month findings.
Time Frame
12 months
Title
Diurnal IOP at 12 months following washout
Description
A 24 month visit will be conducted to confirm 12 month findings
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof. Norbert Pfeiffer, MD
Organizational Affiliation
Universitatsmedizin Mainz
Official's Role
Principal Investigator
Facility Information:
Facility Name
See Central Contact
City
Frankfurt
Country
Germany
Facility Name
See Central Contact
City
Mainz
Country
Germany
Facility Name
See Central Contact
City
Parma
Country
Italy
Facility Name
See Central Contact
City
Torino
Country
Italy
Facility Name
See Central Contact
City
Rotterdam
Country
Netherlands
Facility Name
See Central Contact
City
Madrid
Country
Spain
Facility Name
See Central Contact
City
Zaragoza
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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