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First Author: A.Fea ITALY
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To describe the surgical experience with second generation trabecular micro-bypass stents implanted with a novel injector system in patients with OAG in conjunction with cataract surgery.
The Micro-Invasive Glaucoma Surgery (MIGS) Study Group is a group of visiting surgeons and staff surgeons from North America and Europe, who have visited one investigational site the S.V. Malayan Ophthalmological Center in Yerevan, Armenia to perform surgeries for MIGS studies involving trabecular bypass and suprachoroidal stents.
The iStent inject (Glaukos) is designed with outlet lateral lumens to enhance aqueous flow from the anterior chamber. The design of the G2-M-IS injector is to enable delivery of two stents using one insertion instrument. Previous reports from two initial studies showed IOP ? 21 mmHg without ocular hypotensive medication achieved in a higher proportion of subjects with stent implantation during cataract surgery vs. cataract surgery alone through two years with favorable long-term safety (Buznego 2012 ASCRS). A series of 100 eyes with moderate to advanced glaucoma underwent implantation with two GTS400 stents using the G2-M-IS injector by surgeons involved in the MIGS studies. The intent of these series was to evaluate the intraoperative performance of the G2-M-IS injector, and postoperative outcomes. This report includes preoperative and operative data on 100 eyes, and data through 12 months postoperative on 50 eyes.
Ninety eyes underwent stent implantation only and ten eyes underwent stent implantation during cataract surgery. Mean preoperative IOP was 23.9 (SD 1.6) mmHg on 1.8 (SD 0.6) medications. The mean C/D ratio was 0.8 (SD 0.1); 77% had a C/D ratio of 0.7 or worse. Nine eyes had undergone 11 prior glaucoma surgeries including 7 trabeculectomies and 4 laser trabeculoplasties. Mean IOP decreased from preoperative IOP of 23.9 mmHg to 14.8 mmHg or less at all postoperative time periods. There were no reports of IOP increase ? 10 mmHg vs. preoperative IOP. In the subset of 50 eyes with data available at 12 months postoperative, mean IOP was 14.5 mmHg (SD 2.1). The mean number of ocular hypotensive medications decreased from an average of 1.8 medications preoperatively to 0.3 medications or less at all postoperative time periods. In subjects with data through 12 months, the mean number of medications was 0.2 (SD 0.6); 41 subjects were not taking any ocular hypotensive medication, 6 were on 1 medication and 3 were on 2 medications. Following surgery on a dense cataract, one subject reported with corneal edema. No other adverse events were reported.
Operative and postoperative findings following GTS400 stent implantation with the G2-M-IS injector showed significant postoperative decrease in IOP and medications with a favorable safety outcome. This presentation will also include the authors personal experience implanting GTS400 stents.