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Implantation of trabecular micro-bypass stents and prostaglandin in open-angle glaucoma subjects not previously controlled on two medications

Poster Details

First Author: A.Jünemann GERMANY

Co Author(s):                  

Abstract Details



Purpose:

Significant IOP and medication reduction of IOP through two years following micro-invasive glaucoma surgery (MIGS) with single or multiple trabecular micro-bypass stents in conjunction with cataract surgery has been shown. The MIGS study group evaluated surgery with two stents and use of one postoperative ocular hypotensive medication in OAG subjects previously not controlled with two medications.

Setting:

A total of 36 visiting surgeons and staff surgeons from nine 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.

Methods:

Enrollment consisted of 39 qualified phakic subjects on two ocular hypotensive medications, with medicated IOP ≥ 18 mmHg and ≤ 30 mmHg, and unmedicated (post-washout) IOP ≥ 22 mmHg and ≤ 38 mmHg. Two stents (Glaukos) were implanted through a 1 mm clear corneal incision, and travoprost was prescribed postoperatively. Clinical parameters through 60 months included IOP, fundus/optic nerve exam, slit-lamp, gonioscopy, surgical/postoperative complications and best corrected visual acuity. To date, all subjects have been followed through 18 months postoperatively.

Results:

Forty-four percent of eyes had C:D ratio worse than 0.7. Mean IOP was 22.2 ± 2.0 mmHg before medication washout, and 25.3 ± 1.8 mmHg after washout. Transient hypotony at one week in one subject resolved without intervention or further sequelae by one month. No other subjects presented with complications. All eyes achieved the primary efficacy endpoint of ≥ 20% IOP reduction at Month 12 vs. baseline with reduction of one medication. All subjects also achieved the secondary efficacy endpoint of Month 12 IOP ≤ 18 mmHg. Mean medicated IOP through 18 months was 14.0 mmHg or less. No intraoperative adverse events or serious device-related postoperative adverse events were reported.

Conclusions:

In this series, phakic eyes with OAG not controlled on two medications had sustained IOP control with significantly reduced medication burden through 18 months postoperative. Follow-up will continue through five years postoperatively. FINANCIAL INTEREST: One of more of the authors... receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented, One of more of the authors... travel has been funded, fully or partially, by a company producing, developing or supplying the product or procedure presented

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