THE SAFETY AND EFFECTIVENESS OF THE HYDRUS AQUEOUS IMPLANT FOR LOWERING INTRAOCULAR PRESSURE IN GLAUCOMA PATIENTS UNDERGOING CATARACT SURGERY, A PROSPECTIVE,MULTICENTER, RANDOMIZED, CONTROLLED CLINICAL TRIA

Completed

Conditions: Intraocular pressure
10018307

Registration Number: NL-OMON40947

Lead Sponsor: Ivantis, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

INCLUSION CRITERIA:
Subjects must meet the following inclusion criteria to be eligible for the study eye
* Male and female patients, at least 45 years of age
* An operable age-related cataract with BCVA of 20/40 or worse, eligible for phacoemulsification; if BCVA is better than 20/40, testing with a BAT meter on a medium setting must result in BCVA 20/40 or worse
* A diagnosis of POAG treated with 1 to 4 hypotensive medications
* Optic nerve appearance characteristic of glaucoma
* Medicated IOP <= 31 mmHg
* Diurnal IOP >= 22 mmHg and <= 34 mmHg after wash out of ocular hypotensive medications
* IOP increase >= 3 mmHg after wash out of ocular hypotensive medications
* Visual field examination using Humphrey 24-2 SITA standard, meeting protocol specified minimum criteria for glaucoma defined as:
- Mild: visual field loss on Humphrey visual field testing, with mean deviation (MD) between 0 and -6dB; fewer than 25% of points depressed below the 5% level and fewer than 15% of points depressed below the 1% level on pattern deviation plot; and no point within central 5° with sensitivity <15dB
- Moderate: visual field loss on Humphrey visual field testing, with mean deviation worse than -6dB but no worse than -12dB; fewer than 50% of points depressed below the 5% level, and fewer than 25% of points depressed below the 1% level on pattern deviation plot; no points within central 5° with sensitivity of <=0dB; and only one hemifield containing a point with sensitivity <15dB within
5° of fixation
* In subjects where the VF exam is not confirmatory for glaucomatous defect, retinal nerve fiber layer optical scanning laser imaging supporting ophthalmoscopy findings shall be performed
* Shaffer grade >= III in all four quadrants
* Cup:disc (c:d) ratio <= 0.8
* Absence of peripheral anterior synechiae (PAS), rubeosis or other angle abnormalities that could impair placement of the implant
* Subject is able and willing to attend scheduled follow-up exams for 2 years postoperatively (and up to 5 years postoperatively as part of a post-approval study)
* Subject understands and signs the informed consent;INTRAOPERATIVE ELIGIBILITY CRITERIA
Individuals who meet the following intraoperative eligibility criteria in the study eye will be randomized into the treatment or control arms of this study.;Subjects must have:
* An intact and centered capsulorrhexis
* An intact posterior capsular bag
* A well-centered monofocal IOL placed in the capsular bag
* A clear view of an open angle and visualization of the angle with direct gonioscopy
following intracameral instillation of a miotic agent, and;Subjects must not have:
* Evidence of zonular dehiscence/rupture
* Intraoperative floppy iris syndrome

Exclusion Criteria

EXCLUSION CRITERIA
Excluded from the study will be individuals with the following characteristics. Unless specified otherwise, all ocular criteria refer to the study eye only.
* Closed angle forms of glaucoma
* Congenital or developmental glaucoma
* Secondary glaucoma (such as neovascular, uveitic, pseudoexfoliative, pigmentary, lensinduced,
steroid-induced, trauma induced, or glaucoma associated with increased episcleral venous pressure)
* Use of more than 4 ocular hypotensive medications (combination medications count as two medications)
* Previous argon laser trabeculoplasty, trabeculectomy, tube shunts, or any other prior filtration or cilioablative surgery
* Prior surgery for an ab-interno or ab-externo device implanted in or through the Schlemm*s Canal
* Inability to complete a reliable 24-2 SITA Standard Humphrey visual field on the study eye at screening (fixation losses, false positive errors and false negative errors should not be greater than 33%)
* Use of oral hypotensive medication for glaucoma for treatment of the fellow eye
* Subjects with advanced glaucoma or any subject who presents with an unacceptable risk to the subject of a washout of ocular hypotensive medications
* Best corrected visual acuity worse than 20/80 in the fellow eye
* A 24-2 SITA Standard Humphrey visual field mean deviation (MD) of worse than -12dB in the fellow eye
* Central corneal thickness > 620 microns and < 480 microns
* Proliferative diabetic retinopathy
* Previous surgery for retinal detachment
* Previous corneal surgery or clinically significant corneal dystrophy, e.g., Fuch*s dystrophy (>12 confluent guttae)
* Unclear ocular media preventing visualization of the fundus or anterior chamber angle
* Degenerative visual disorders such as wet age-related macular degeneration
* Clinically significant ocular pathology, other than cataract and glaucoma
* Clinically significant ocular inflammation or infection within 6 months prior to screening
* Presence of extensive iris processes that obscure visualization of the trabecular meshwork
* Unable to discontinue use of blood thinners in accordance with surgeon*s standard postoperative instructions
* Known or suspected elevated episcleral venous pressure due to Sturge Weber, nanophthalmos, orbital congestive disease
* Uncontrolled systemic disease that in the opinion of the Investigator would put the subject*s health at risk and/or prevent the subject from completing all study visits
* Current participation or participation in another investigational drug or device clinical trial (which includes the fellow eye) within the past 30 calendar days
* Pregnant or nursing women; or women of child bearing age not using medically acceptable contraceptives

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome parameters will include:<br /><br><br /><br>Effectiveness<br /><br>The primary effectiveness endpoint for this study is:<br /><br>• Reduction of at least 20% (i.e., >= 20%) in mean diurnal IOP from baseline at<br /><br>24 months following medication washout.<br /><br><br /><br>Safety<br /><br>• Safety outcomes include loss of lines of BCVA, slit lamp and fundus<br /><br>examination findings, ECD change, and the incidence of complications and<br /><br>adverse events.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary effectiveness endpoint for this study is:<br /><br>• The mean diurnal IOP change from baseline at 24 months will be compared<br /><br>between the Hydrus and control groups.</p><br>