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First Author: G.Auffarth GERMANY
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Trabecular bypass therapy offers the advantage of restoration of natural physiologic outflow in OAG. IOP and medication reduction following multiple trabecular bypass stent implantation have shown the value of this technology as titratable therapy to reduce IOP to ? 15 mmHg with sustained efficacy and safety.To achieve further IOP reduction in refractory OAG, the combined use of trabecular bypass with either a topical glaucoma medication or a suprachoroidal stent may be considered. The purpose of this study was to assess intraocular pressure (IOP) lowering effects of two trabecular bypass stents, one suprachoroidal stent and postoperatively prescribed travoprost in refractory OAG previously not controlled following treatment with trabeculectomy and medications.
The MIGS Study Group includes visiting surgeons and staff surgeons from seven countries in North America and Europe. These surgeons have performed surgeries at one investigational site the S.V. Malayan Ophthalmological Center in Yerevan, Armenia.
Prospective study by the Micro-Invasive Glaucoma Surgery (MIGS) Study Group.Phakic or pseudophakic subjects with OAG and IOP between 18 mmHg and 45 mmHg following trabeculectomy, use of 1 to 3 ocular hypotensive medications were enrolled. Subjects deemed by the investigator not eligible for medication washout (e.g., visual field status would be at risk by washout; IOP after washout expected to be > 45 mmHg) were excluded.After medication washout, 80 eligible subjects with unmedicated IOP ? 21 mmHg and ? 45 mmHg were implanted with two iStents and one iStentsupra (Glaukos). One year efficacy endpoints were IOP reduction ? 20% and IOP ? 15 mmHg. Slit-lamp and optic nerve evaluation, BCVA and adverse events comprise the safety evaluation through five years.
To date, 50 subjects have been enrolled and 30 subjects have presented at 6 months. Mean screening medicated IOP was 22.9 (SD 3.4; range 18-36) mmHg. Mean baseline IOP after medication washout was 26.5 (SD 2.6; range 22-35) mmHg. Month 6 IOP was 12.4 (SD 1.5) mmHg, representing a 52% IOP reduction. Medications were reduced from 1.3 (SD 0.5) preoperatively to one postoperatively. No intraoperative or postoperative ocular adverse events were reported to date.
Six month results in this study of two trabecular bypass stents, onesuprachoroidal stent and one postoperative medication in refractory OAG subjects showed significant IOP reduction, reduction in drug burden, and overall favorable safety profile.