Clinical Data

The INTEGRITY Study1

The first prospective, randomized, multinational, double-masked head-to-head study comparing iStent infinite® vs Hydrus Microstent in a standalone procedure.

The interim 6-month data suggests iStent infinite® is statistically superior or has clinically superior outcomes compared to Hydrus Microstent.

Study Overview

  • LARGEST HEAD-TO-HEAD, PROSPECTIVE RCT
    • Largest prospective RCT comparing trabecular bypass devices in patients with POAG; 180 eyes in total (91 iStent infinite®, 89 Hydrus Microstent)

  • 180 EYES
    • 180 eyes in total (91 iStent infinite®, 89 Hydrus Microstent)

  • 7 SITES | 13 SURGEONS
    • 7 sites with 13 experienced iStent infinite® and Hydrus Microstent surgeons

  • MEDICATION WASHOUT
    • Per protocol, medication washout deployed at baseline and predetermined timepoints (6 months, 12 months, 24 months)

  • STANDALONE IMPLANTATION
    • Standalone implantation of iStent infinite® or Hydrus Microstent

  • PROSPECTIVELY DEFINED PRIMARY AND SECONDARY OUTCOMES
    • Mean change in Month 12 MDIOP from baseline
    • Unmedicated MDIOP reduction >20% from baseline at Month 6 with no pertinent safety findings*
    • Safety parameters: intraoperative/postoperative complications, corrected visual acuity, slit-lamp and fundus examinations, gonioscopy, visual field testing, and adverse events

RCT=randomized controlled trial.

POAG=primary open-angle glaucoma.

MDIOP=mean diurnal intraocular pressure.

Month 6 Findings

More iStent infinite® eyes had a ≥20% reduction in unmedicated diurnal IOP from baseline with no surgical complications*

≥20% reduction

More iStent infinite® eyes had ≥30% reduction in unmedicated diurnal IOP (P > 0.05)

≥30% reduction

A statistically significant and clinically meaningful reduction in diurnal IOP from baseline was observed in iStent infinite® eyes

A greater proportion of iStent infinite® eyes had lower unmedicated post-op mean diurnal IOPs

Fewer intraoperative and postoperative adverse events were observed with iStent infinite®

*Surgical complications include damage to crystalline lens, failure to implant stent, improper anatomical placement, iridodialysis and iridectomy, iris prolapse, peripheral anterior synechiae > 1 mm, vitreous prolapse due to significant capsular tear/rupture

Reference

  1. Glaukos Data on File.

Trademarks are the property of their respective owners.

Hydrus is a registered trademark of Alcon, Inc. Image of Hydrus from https://www.myalcon.com/professional/cataract-surgery/hydrus-microstent/

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iStent inject® W Important Safety Information

Indication For Use

The iStent inject® W (Model G2-W) is intended to reduce intraocular pressure safely and effectively in patients diagnosed with primary open-angle glaucoma, pseudo-exfoliative glaucoma or pigmentary glaucoma. The iStent inject® W can deliver two (2) stents on a single pass, through a single incision. The implant is designed to open a passage through the trabecular meshwork allowing for increased facility of outflow and a subsequent reduction in intraocular pressure. The device is safe and effective when implanted in combination with cataract surgery in those subjects who require intraocular pressure reduction and/or would benefit from glaucoma medication reduction. The device may also be implanted in patients who continue to have elevated intraocular pressure despite prior treatment with glaucoma medications and conventional glaucoma surgery.

Contraindications

In eyes with primary angle-closure glaucoma, or secondary angle-closure glaucoma, including neovascular glaucomas, in patients with retrobulbar tumor, thyroid eye disease, Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure.

Warnings

This device has not been studied in patients with uveitic glaucoma. The surgeon should monitor the patient postoperatively for proper maintenance of intraocular pressure. iStent inject® W is MR-Conditional meaning that the device is safe for use in a specified MRI environment under specified conditions; please see labeling for details. Physician training is required prior to use. Do not re-use the stent(s) or inserter.

Adverse Events

Postoperative adverse events include but are not limited to: early postoperative corneal edema, posterior capsule opacification, stent obstruction, intraocular inflammation (non-preexisting), BCVA loss, and IOP increase requiring management with oral or intravenous medications or surgical intervention. Please refer to Directions for Use for additional adverse event information.

Caution

Please reference Directions for Use labeling for a complete list of contraindications, warnings and adverse events

iStent inject® ISI