Overview

This trial is active, not recruiting.

Conditions primary open angle glaucoma, glaucoma, open angle, pseudo-exfoliative, cataract unilateral pending extraction
Treatments hydrus implant, iol placement
Phase phase 3
Sponsor Ivantis, Inc.
Start date January 2011
End date September 2014
Trial size 100 participants
Trial identifier NCT01818115, CP-10-001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
Cataract extraction with intraocular lens (IOL) placement and Hydrus Implant
hydrus implant
(Active Comparator)
Cataract Extraction with IOL placement only.
iol placement

Primary Outcomes

Measure
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.
time frame: 24 months

Secondary Outcomes

Measure
Reduction in mean washed out IOP at 24 months
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.
time frame: 12 months
The proportion of eyes with IOP >5 mmHg to ≤19 mmHg following terminal washout.
time frame: 12 months
Diurnal IOP at 12 months following washout
time frame: 12 months

Eligibility Criteria

Male or female participants from 21 years up to 80 years old.

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.

Additional Information

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.
Principal investigator Prof. Norbert Pfeiffer, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by Ivantis, Inc..