Back to Freepaper Session

Intraocular pressure reduction and safety outcomes following micro-invasive glaucoma surgery with two trabecular micro-bypass stents in OAG

Session Details

Session Title: Glaucoma

Session Date/Time: Monday 07/10/2013 | 17:00-18:34

Paper Time: 18:20

Venue: Elicium 2 (First Floor)

First Author: : D.Chang USA

Co Author(s): :                  

Abstract Details

Purpose:

Significantly lower IOP and ocular hypotensive medication use has been shown following micro-invasive glaucoma surgery (MIGS) involving ab interno implantation of single or multiple trabecular micro-bypass stents during cataract surgery. The purpose of this study was to evaluate intraocular pressure reduction and safety outcomes 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 were implanted with two trabecular bypass stents (Glaukos). Ocular hypotensive medication was prescribed postoperatively if IOP exceeded 21 mmHg. One year efficacy endpoints were unmedicated IOP reduction ? 20%, unmedicated IOP ? 18 mmHg and mean change in IOP. Safety assessment included fundus exam/optic nerve evaluation, slit-lamp findings, best corrected visual acuity, and complications/adverse events through two years. All subjects have been followed through one year postoperative.

Results:

Mean preoperative medicated IOP was 20.6 mmHg (SD 2.0), and unmedicated (baseline) IOP was 24.1 mmHg (SD 1.4). IOP decreased to 14.2 mmHg (SD 3.4) at 1 month, 13.7 mmHg (SD 3.0) at 3 months, 13.3 mmHg (SD 1.5) at 6 months and 13.6 (1.9) at 12 months. At 12 months, 37 of 39 subjects were on no medications, one subject was on one medication, and one subject was on two medications. A small hyphema in one subject one week postoperative had resolved by one month.

Conclusions:

Micro-invasive glaucoma surgery (MIGS) involving implantation of two trabecular stents in this series of OAG subjects not controlled on medication resulted in significant reduction in mean postoperative IOP to 14.2 mmHg or lower through 12 months, significant reduction in medication burden, and a favorable safety profile.

Financial Interest:

... receives consulting fees, retainer, or contract payments from a competing company, ... travel has been funded, fully or partially, by a company producing, developing or supplying the product or procedure presented