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Intraocular pressure reduction thirty months postoperative following microinvasive glaucoma surgery with two trabecular micro-bypass stents in OAG

Poster Details

First Author: G.Auffarth GERMANY

Co Author(s):    M. Study Group              

Abstract Details



Purpose:

The purpose of this study was to evaluate intraocular pressure reduction and safety outcomes through 30 months following micro-invasive glaucoma surgery (MIGS) to implant two trabecular micro-bypass stents as the sole procedure in subjects with open angle glaucoma (OAG) not controlled on one ocular hypotensive medication. This study is one in a series of studies by the MIGS Study Group

Setting:

The MIGS Study Group is comprised of visiting surgeons and staff surgeons from seven countries worldwide performing surgeries at one investigational site - The S.V. Malayan Ophthalmological Center in Yerevan, Armenia

Methods:

Phakic or pseudophakic subjects with OAG not controlled on one ocular hypotensive medication, with CD ratio 0.95 or lower, and IOP between 18 mmHg and 30 mmHg were enrolled. Following medication washout, 39 qualified subjects with IOP between 22 mmHg and 38 mmHg underwent implantation of two trabecular bypass stents (Glaukos). Ocular hypotensive medication was prescribed postoperatively if IOP exceeded 21 mmHg. The primary efficacy endpoint was Month 12 IOP reduction of ≥ 20% without medication, and the secondary efficacy endpoint was Month 12 IOP ≤ 18 mmHg without medication. Safety assessment included fundus exam/optic nerve evaluation, slit-lamp findings, best corrected visual acuity, and complications/adverse events through two years

Results:

Mean preoperative medicated IOP was 20.6 mmHg (SD 2.0), and unmedicated (baseline) IOP was 24.1 mmHg (SD 1.4). Thirty-one subjects have been followed through 30 months. Mean IOP decreased to 15.1 mmHg at all postoperative time periods. At 30 months, mean IOP was 15.1 mmHg (SD 2.0). Ninety-two percent of eyes achieved each of the Month 12 efficacy endpoints. A small hyphema in one subject one week postoperative had resolved by one month. Three of four subjects who experienced BCVA loss of ≥ 1 line postoperatively due to progression of pre-existing cataract underwent cataract surgery. The fourth subject experienced BCVA loss from 20/30 at the preoperative exam to 20/50 at Month 24. No other adverse events have been observed to date

Conclusions:

In this MIGS study, significant IOP and medication reduction was achieved. The majority of eyes achieved Month 12 IOP reduction ≥ 20% without medication and Month 12 IOP ≤ 18 mmHg without medication. IOP reduction was sustained through Month 30. These eyes with OAG not controlled on one medication achieved IOP control with reduced medication burden after implanta-tion of two trabecular micro-bypass stents. Follow-up is ongoing FINANCIAL INTEREST: One of more of the authors... research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented

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