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

Proportion of Eyes with Month 6 Unmedicated MDIOP Reduction from Baseline ≥ 20%
(Excluding all intercurrent events)

Month 6 Unmedicated MDIOP Reduction from Baseline
(Excluding all intercurrent events)

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®

Improper anatomical placement

iStent infinite®

Hydrus Microstent

Peripheral anterior synechiae (>1mm)

iStent infinite®

Hydrus Microstent

*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/

iStent infinite® Important Safety Information

Indication for Use

The iStent infinite® Trabecular Micro-Bypass System Model iS3 is an implantable device intended to reduce the intraocular pressure (IOP) of the eye. It is indicated for use in adult patients with primary open-angle glaucoma in whom previous medical and surgical treatment has failed.

Contraindications

The iStent infinite is contraindicated in eyes with angle-closure glaucoma where the angle has not been surgically opened, acute traumatic, malignant, active uveitic, or active neovascular glaucoma, discernible congenital anomalies of the anterior chamber (AC) angle, retrobulbar tumor, thyroid eye disease, or Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure.

Warnings

Gonioscopy should be performed prior to surgery to exclude congenital anomalies of the angle, PAS, rubeosis, or conditions that would prohibit adequate visualization that could lead to improper placement of the stent and pose a hazard.

MRI Information

The iStent infinite is MR-Conditional, i.e., the device is safe for use in a specified MR environment under specified conditions; please see Directions for Use (DFU) label for details.

Precautions

The surgeon should monitor the patient postoperatively for proper maintenance of IOP. Three out of 61 participants (4.9%) in the pivotal clinical trial were phakic. Therefore, there is insufficient evidence to determine whether the clinical performance of the device may be different in those who are phakic versus in those who are pseudophakic.

Adverse Events

The most common postoperative adverse events reported in the iStent infinite pivotal trial included IOP increase ≥ 10 mmHg vs. baseline IOP (8.2%), loss of BSCVA ≥ 2 lines (11.5%), ocular surface disease (11.5%), perioperative inflammation (6.6%) and visual field loss ≥ 2.5 dB (6.6%).

Caution

Federal law restricts this device to sale by, or on the order of, a physician. Please see DFU for a complete list of contraindications, warnings, precautions, and adverse events.


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