Clinical Data

iStent inject® Clinical Data

Trabecular micro-bypass technology developed by Glaukos has been studied extensively around the world and its efficacy has been demonstrated in 75 peer-reviewed articles, 5 years of clinical use, and over 300,000 eyes.

The implantation of two trabecular bypass stents – without the benefit of cataract surgery – has shown in prospective clinical trials to both lower IOP to <15 mm Hg and reduce medication burden via a unique two stent approach:

CAN REDUCE INTRAOCULAR PRESSURE (IOP) AND MEDICATION BURDEN

Numerous studies have demonstrated that iStent inject® is effective in lowering IOP and can reduce medication burden.

In one notable consecutive case study involving multiple international surgeons, a mean IOP reduction of 34% vs. medicated screening (13.6 mmHg vs. 20.6 mmHg) was found at 12 months.1 Additionally, average medication usage was reduced from 1.0 to 0.1.1

At 12 month post-operative visit:

Another study conducted by multiple international surgeons demonstrated a mean IOP reduction of 47% vs. medicated screening at 18 months, finding that stents alone lowered IOP 5.1 mmHg from medicated screening.2

At 18 month post-operative visit:

In the 12-month postoperative visit of the Synergy Study, a multi-centre study conducted in Europe, subjects who remained off medication demonstrated a mean IOP reduction of 34% as compared to the medicated screening.3 The Synergy Study also showed that 72% of patients experienced IOP reduction ≥20% without elimination of medication at 12 months postoperative.3

At 12 month post-operative visit:

Important Safety Information »

1. Chang, DF. Intraocular Pressure Reduction and Safety Outcomes After Micro-Invasive Glaucoma Surgery with 2 Trabecular Bypass Stents in OAG. Presented at the 2013 American Society of Cataract and Refractive Surgery Annual Meeting; April 19-23, 2013; San Francisco, California, USA.
2. Samuelson TW. Outcomes of MIGS with Trabecular Micro-Bypass Stents and Prostaglandin in Open-Angle Glaucoma Subjects. Presented at the 2013 American Society of Cataract and Refractive Surgery Annual Meeting; April 19-23, 2013; San Francisco, California, USA.
3. Voskanyan L, García-Feijoó J, Belda J, Fea A, Jünemann A, Baudouin C. “Prospective, Unmasked Evaluation of the iStent inject System for Open-Angle Glaucoma: Synergy Trial”. Adv Ther 2014; 31:189-201.

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