Clinical Data

Clinical Data

Trabecular micro-bypass technology developed by Glaukos has been studied extensively around the world and its efficacy has been demonstrated in 55 peer-reviewed articles, 5 years of clinical use, and over 300,000 eyes.

REDUCED INTRAOCULAR PRESSURE (IOP)

Numerous studies have demonstrated that iStent inject® is effective in lowering IOP.

In one notable study, 63% of eyes had IOP ≤18 mmHg and 69% had IOP reduction ≥ 20% without medication at 24 months.1

Another study published by Hengerer, et al., demonstrated substantial reductions in IOP. At 18 months, mean presented IOP was 13.6 ±1.9 mmHg, representing a 48% decrease from preoperative mean medicated IOP.2

A second line study, conducted by Fea, et.al, in Europe, showed that the use of iStent inject® is at least as effective as two medications. At the 12-month vision subjects in the stent group reported an unmedicated intraocular pressure reduction of ≥20% versus baseline IOP.3

Additionally, in the 12-month postoperative visit of the Synergy Study, a multi-center study conducted in Europe, subjects who remained off mediation demonstrated a mean IOP reduction of 34% as compared to the medicated screening.4

REDUCTION IN GLAUCOMA MEDICATION

In the Hengerer, et al. study, 87% were either medication free or on only 1 medication at 18 months. Additionally, overall mean medication use was lowered by 2.1 medications, representing a 76% decrease in mean medication burden.2

The Synergy Study showed that 72% of patients experienced IOP reduction ≥20% without elimination of medication at 12 months postoperative.4

SAFETY

The iStent inject® procedure spares conjunctival tissue and preserves the potential for future treatment options. Additionally, a natural episcleral back pressure of 8-11 mm Hg in the trabecular meshwork reduces the risk of hypotony.

Important Safety Information »

1. Data on File GC-005 and GC-006
2. Hengerer FH, Müller M, Conrad-Hengerer I, Kohnen T. “Personal experience and outcomes through eighteen months following implantation of second generation trabecular micro-bypass stents in patients with open-angle glaucoma”. Presented at the 2016 European Society of Cataract and Refractive Surgery Annual Meeting; September 13-17, 2016; Copenhagen, Denmark.
3. Fea A, et al. Clin Ophthalmol. 2014; 8:875-882
4.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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