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First Author: L.Nichamin USA
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Micro-Invasive Glaucoma Surgery (MIGS) incorporates advantages of ab interno surgery through a clear corneal micro-incision to enhance natural physiologic outflow via a patent bypass. Over 4,100 iStents have been evaluated in over 30 studies worldwide for over ten years. Several prospective, randomized studies and smaller single-surgeon studies of iStent, iStent inject® and iStent supra® have produced long-term data. This presentation will summarize results of these studies.
Twenty visiting surgeons and staff surgeons from seven countries comprise the MIGS Study Group and have performed MIGS studies of iStent at the S.V. Malayan Ophthalmological Center in Yerevan, Armenia.
In addition to the first large-scale, prospective, randomized controlled study in Open Angle Glaucoma (OAG) of iStent at 29 investigational sites in the U.S., several single-surgeon studies have also been conducted in Canada, Italy, Germany, Spain and the UK. Second generation trabecular bypass stents and suprachoroidal stents have been studied in prospective, randomized trials in U.S. and MIGS study groups, with data through two years.
In the U.S. prospective study of the first generation trabecular bypass stent with cataract surgery vs. cataract surgery alone results through two years postoperative on 240 subjects with mild to moderate OAG and cataract showed a significant treatment effect in favor of the iStent group, with an overall long-term safety profile similar to cataract surgery alone. A significant treatment effect through five years postoperative was shown in a single-surgeon study in Italy with a study design similar to the U.S. trial. Single-surgeon studies in Germany, the UK and Spain also showed IOP and medication reduction up to five years postoperative following iStent implantation during cataract surgery.
Significant long-term IOP and medication reduction with a high safety profile was achieved in various prospective studies of MIGS implantation of iStents in OAG subjects. These studies provide strong evidence that ab interno iStent implantation is a safe and effective therapy for IOP control in OAG.
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