SEP 2023

EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.

Issue link: https://digital.eyeworld.org/i/1504856

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Page 82 of 82

REFERENCE 1. Glaukos Data on File. iStent infinite® IMPORTANT SAFET Y 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 patient s with primar y 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, ac tive uveitic, or ac tive neovascular glaucoma, discernible congenital anomalies of the anterior chamber (AC) angle, retrobulbar tumor, thyroid eye disease, or Sturge-Weber Syndrome or any other t ype of condition that may cause elevated episcleral venous pressure. WARNINGS. Gonioscopy should be per formed prior to surger y to exclude congenital anomalies of the angle, PA S, 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 Direc tions for Use (DFU) label for details. PRECAUTIONS. The surgeon should monitor the patient postoperatively for proper maintenance of IOP. Three out of 61 par ticipant s (4.9%) in the pivotal clinical trial were phakic. Therefore, there is insuf ficient evidence to determine whether the clinical per formance of the device may be dif ferent in those who are phakic versus in those who are pseudophakic. ADVERSE EVENTS. The most common postoperative adverse event s repor ted in the iStent infinite pivotal trial included IOP increase ≥ 10 mmHg vs. baseline IOP (8.2%), loss of BSC VA ≥ 2 lines (11.5%), ocular sur face disease (11.5%), perioperative inflammation (6.6%) and visual field loss ≥ 2.5 dB (6.6%). CAUTION: Federal law restric t s 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 event s. Glaukos® and iStent infinite® are registered trademarks of Glaukos Corporation. All right s reser ved. ©2022 PM-US- 0909 Brought to you by the founder of MIGS, iStent infinite ® is the first-ever micro-invasive, standalone implantable alternative. Built on the #1 MIGS platform worldwide, it is designed to provide powerful technology that delivers foundational, 24/7, long-term IOP control in glaucoma patients who have failed prior medical and surgical intervention. 1 T H E P O W E R O F 3 The Beginning of the Interventional Glaucoma Revolution infinite possibilities

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