Clinical trial NCT01818115: Safety and Efficacy Trial to Evaluate the Hydrus(TM) Implant in Subjects Undergoing Cataract Surgery.
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
Overall status: COMPLETED
Phase: NA
Conditions: Primary Open Angle Glaucoma
Glaucoma, Open Angle, Pseudo-exfoliative
Cataract Unilateral Pending Extraction
Keywords: POAG
PXG
IOL Surgery
CE Surgery
Lead sponsor: Ivantis, Inc.
Sponsor class: INDUSTRY
First posted: 2013-03-26
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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.
timeFrame: 24 months
Secondary outcomes:
measure: Reduction in mean washed out IOP at 24 months
timeFrame: 24 months
measure: Change in Best-corrected Visual Acuity (BCVA) from baseline to 12 months as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart.
timeFrame: 12 months
measure: The proportion of eyes with IOP >5 mmHg to ≤19 mmHg following terminal washout.
timeFrame: 12 months
measure: Diurnal IOP at 12 months following washout
timeFrame: 12 months
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: See Central Contact
city: Mainz
country: Germany
facility: See Central Contact
city: Parma
country: Italy
facility: See Central Contact
city: Torino
country: Italy
facility: See Central Contact
city: Rotterdam
country: Netherlands
facility: See Central Contact
city: Madrid
country: Spain
facility: See Central Contact
city: Zaragoza
country: Spain
facility: See Central Contact
Study officials:
affiliation: Universitatsmedizin Mainz
name: Prof. Norbert Pfeiffer, MD
role: PRINCIPAL_INVESTIGATOR
References: