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First Author: J.Garcia-Feijoo SPAIN
Co Author(s): J. Martinez de la Casa
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In this study, the Micro-Invasive Glaucoma Surgery (MIGS) Study Group evaluated IOP and safety outcomes following implantation of two trabecular bypass stents as the sole surgical procedure and use of one postoperative medication in open angle glaucoma (OAG) previously not controlled with two medications.
A total of eighteen visiting surgeons and staff surgeons from seven countries worldwide comprise the MIGS Study Group. The S.V. Malayan Ophthalmological Center in Yerevan, Armenia is the investigational site at which surgeries have been performed for this and the other MIGS studies.
This prospective study enrolled 41 qualified phakic or pseudophakic eyes with OAG. Subject enrollment criteria included a preoperative regimen of two medications, medicated IOP ? 18 mmHg and ? 30 mmHg, and IOP ? 22 mmHg and ? 38 mmHg following a preoperative medication washout step. Subjects underwent implantation of two trabecular bypass stents via a micro-invasive surgical procedure. Travoprost was prescribed postoperatively. Subjects were evaluated at Day 1, Week 1, and at 1, 3, 6, 12, 13, 18, 24 and 25 months postoperative. The primary efficacy endpoint was ? 20% IOP reduction with reduction of one medication. Clinical parameters included IOP, fundus/optic nerve exam, slit-lamp assessment, gonioscopy, surgical and postoperative complications and best corrected visual acuity.
All eyes have been followed through one year postoperative. The average age was 64 ±12 years, and 85% of eyes were phakic. All subjects were taking two ocular hypotensive medications prior to surgery. The mean C/D ratio was 0.7 ±0.1, and 62% of eyes had a C/D ratio of 0.7 or worse. Mean IOP prior to medication washout was 22.3 ±2.3 mmHg, and IOP after washout was 25.3 ±1.8 mmHg. All subjects underwent uncomplicated ab interno implantation of two stents through a 1 mm clear corneal incision. One subject presented with transient hypotony at one week that had resolved without intervention or further sequelae by the one month visit. Mean IOP on one postoperative ocular hypotensive medication (vs. two preoperatively) was 14.1 ±2.6 mmHg at 1 month, 13.9 ±2.0 mmHg at 3 months, 13.3 ±1.9 mmHg at 6 months, and 13.0 ±2.4 mmHg at 12 months. The primary endpoint of ? 20% IOP reduction with reduction of one medication was met in all eyes, with a mean reduction of 48%. All subjects achieved IOP ? 18 mmHg, and 83% achieved IOP ? 15 mmHg.
In this MIGS study, phakic/pseudophakic eyes with OAG not controlled on two medications achieved IOP control with a significantly reduced medication burden through 12 months postoperative after MIGS implantation of two trabecular micro-bypass stents.
... receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented, ... research is funded, fully or partially, by a competing company, ... research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented, ... receives consulting fees, retainer, or contract payments from a competing company