Ivantis Hydrus Aqueous Implant for Lowering Intraocular Pressure in Glaucoma Patients Undergoing Cataract Surgery

Principal Investigator: Alan Crandall
Keywords: Cataract , Glaucoma Department: Ophthalmology-Services
IRB Number: 00071040 Co Investigator:  
Specialty: Ophthalmology, Ophthalmology, Ophthalmology
Sub Specialties: Glaucoma, Cataract Surgery,
Recruitment Status: Active, not recruiting

Contact Information

Kara Halsey
kara.halsey@hsc.utah.edu
801-213-2034

Brief Summary

The objective of this study is to demonstrate the safety and effectiness of the Hydrus Aqueous Implant for lowering IOP in patients with primary open-angle glaucoma (POAG) who are undergoing concurrent cataract surgery

Inclusion Criteria

Male and female patients, at least 45 years of age.

An operable age-related cataract with best corrected visual acuity of 20/40 or worse, eligible for phacoemulsification; if best corrected visual acuity 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 primary open angle glaucoma treated with 1 to 4 hypotensive medications

Optic nerve appearance characteristic of glaucoma.

Medicated IOP less than or equal to 31 mmHg.

Dirunal IOP greater than or equal to 22 mmHG and less than or equal to 34 mmHg after washout of ocular hypotensive medications.

Visual field examination using Humphrey 24-2 SITA standard, meeting the following minimum criteria for glaucoma:

- 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 degree with sensitivity less than 15 dB.

- 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 5% with sensitivity of less than equal to 0dB; and only one hemifield containing a point with sensitivity less than 15 dB within 5 degrees of fixation.

 

In subjects where the visual field exam is not confirmatory for glaucomatous defect, retinal nerve fiber layer optical scanning laser imaging supporting ophthalmoscopy findings shall be performed.

Shaffer grade greater than or equal to III in all four quadrants.

Cup:disc (c:d) ratio less than or equal to 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 post-operatively (and up to 5 years postoperatively as part of a post-approval study).

Subject understands and signs the informed consent.

INTRAOPERATIVE ELIGIBLITY CRITERIA:

Individuals who meet the following intraoperative eligibilty criteria in the study eye will be randomzied 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 agle and visualization of the angle with direct goniosopy following intracameral instillation of a miotic agent, and

Subjects must not have:

- Evidence of zonular dehiscence/rupture

- Intraoperative floppy iris syndrome

Exclusion Criteria

Closed angle forms of glaucoma

Congenital or developmental glaucoma

Secondary glaucoma (such as neovascular, uveitic, pseudoexfoliative, pigmentary, lens-induced, steroid-induced, trauma induced, or glaucoma associated wtih 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 -12 dB in the fellow eye.

Central corneal thickness greater than 620 microns and less than 480 microns.

Proliferative diabetic retinopathy

Previous surgery for retinal detachment

Previous corneal surgery or clinically signficiant corneal dystrophy, e.g., Fuch's dystrophy (greater than 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, anopthalmos, orbital congestive disease.

Uncontrolled systemic disease that in the opinion of the Investigator would put the subject's health at risk and/or preven 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.