Clinical Data
In the prospective, multicenter, 12-month pivotal trial, patients with open-angle glaucoma who had failed prior surgical intervention or were on maximal tolerated medication underwent standalone iStent infinite® implantation.1
Of note, patients enrolled in this study had a significantly higher preoperative treatment burden with more severe glaucoma as compared to other trabecular bypass MIGS pivotal trials.1,2,3,4
* Reduction from baseline at 12 months on the same or fewer medications.
For a complete list of postoperative adverse events, please review the Important Safety Information in the Instructions for Use.
The iStent infinite® System is intended to reduce intraocular pressure safely and effectively in adult patients diagnosed with primary open-angle glaucoma, pseudo-exfoliative glaucoma or pigmentary glaucoma. The device is safe and effective when implanted in combination with or without 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/or conventional glaucoma surgery.
The iStent infinite® System is contraindicated under the following circumstances or conditions: In eyes with primary angle closure glaucoma, or secondary angle-closure glaucoma, including neovascular glaucoma, because the device would not be expected to work in such situations; In patients with retrobulbar tumor, thyroid eye disease, Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure.
Gonioscopy should be performed prior to surgery to exclude congenital anomalies of the angle, PAS, rubeosis, or conditions that would prohibit adequate visualisation that could lead to improper placement of the stent and pose a hazard.
The iStent infinite® System 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.
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.
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%).
For prescription use only. Please see DFU for a complete list of contraindications, warnings, precautions, and adverse events.