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Initial outcomes with second-generation trabecular micro-bypass stents (iStent inject®) implanted in conjunction with phacoemulsification: single US surgeon's experience

Poster Details

First Author: S.Sarkisian USA

Co Author(s):                        

Abstract Details

Purpose:

This study aims to evaluate the safety and performance of two 2nd generation trabecular micro-bypass stents (iStent inject) implanted in combination with cataract surgery as a surgical treatment for glaucoma. Given the recent introduction of this technology to the US and regions of Europe (i.e., France), reports of real-world evidence on the usage of iStent inject is important.

Setting:

Private ophthalmology practice in Oklahoma City, Oklahoma, USA.

Methods:

This is a retrospective, consecutive case series of a single surgeon with long-term data collection planned. To date, 31 eyes (from 16 females and 15 males) have been successfully implanted with 2 iStent inject in conjunction with cataract surgery. Assessments included intraocular pressure (IOP) and medication use in addition to standard safety evaluations. Continued patient monitoring and data collection of iStent inject cases is planned with the intent of reporting a larger sample size with longer-term outcomes by the time of the presentation.

Results:

The average age of the 31 patients in this cohort was 67.9 years. Preoperatively, the mean IOP was 17.3 ± 5.1 mmHg on 1.2 ± 1.2 medications. Given the early usage of this device, only 1 month postoperative follow-up has been reached. At Month 1, mean IOP was 13.7 ± 3.6 mmHg on 0.4 ± 1.0 medications, representing a 3.6 mmHg IOP reduction (21%) and 67% reduction in the number of medications. Eighty-five percent (85%) of eyes were medication-free at Month 1 compared to 42% prior to surgery. Favorable safety was observed with no significant intraoperative or postoperative complications.

Conclusions:

Early clinical experience with the iStent inject trabecular stents demonstrated clinically meaningful IOP and medication reduction. A high safety profile has been observed to date with no significant intra- or postoperative complications.  With the increasing popularity of trabecular micro-bypass surgery to treat open-angle glaucoma, iStent inject adds to the existing micro-invasive procedures available. As surgeons in the US and in regions of Europe (i.e., France) are introduced to the recently available iStent inject, clinical evidence from real-world usage is needed.

Financial Disclosure:

... is employed by a for-profit company with an interest in the subject of the presentation

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