Posters

Prospective evaluation of iStent inject® trabecular micro-bypass implantation combined with a topical prostaglandin: four-year outcomes

Poster Details

First Author: J.Myers USA

Co Author(s):                        

Abstract Details

Purpose:

To evaluate the long-term outcomes after treatment with iStent inject® (second-generation trabecular micro-bypass stents) implanted as a standalone procedure combined with a topical prostaglandin in subjects with open-angle glaucoma (OAG) on 2 preoperative medications.

Setting:

All surgeries and follow-up visits were completed at the S.V. Malayan Ophthalmological Center in Yerevan, Armenia.

Methods:

This prospective study enrolled subjects with OAG on 2 ocular hypotensive medications and with preoperative intraocular pressure (IOP) of 18-30 mmHg (medicated) and 22-38 mmHg (post-washout).  All subjects underwent trabecular micro-bypass stent surgery in the form of standalone implantation of 2 iStent inject stents, and topical travoprost was started on postoperative Day 1.   Assessments through month 48 included IOP, medications, adverse events, best-corrected visual acuity (BCVA), visual fields (VF), and findings from slit-lamp, gonioscopic, optic nerve, and funduscopic examinations. Annual medication washout was performed.  Postoperative safety and efficacy evaluation through 5 years is ongoing.

Results:

All 53 enrolled subjects underwent uncomplicated iStent inject implantation and completed 49 months of follow-up.  At month 48 postoperative, mean medicated IOP was 13.1 mmHg versus 19.7 mmHg preoperatively (34% reduction). After washout at month 49, mean unmedicated IOP was 17.7 mmHg versus 24.9 mmHg preoperatively (29% reduction). Postoperative mean medicated IOP remained ≤13.1 mmHg at all visits through month 48. Ninety one percent (91%) of subjects achieved month 48 IOP ≤18 mmHg on travoprost; 81% achieved IOP ≤15 mmHg on travoprost.  BCVA, cup:disc (C:D) ratio, and VF mean deviation remained stable through month 48 versus preoperative measures.

Conclusions:

This study demonstrates sustained 4-year IOP and medication reductions in OAG eyes with IOP not controlled on 2 medications implanted with iStent inject as a standalone surgery combined with postoperative topical travoprost. Favorable safety outcomes were observed consistent with published reports in the literature. The study outcomes support the use of iStent inject® plus travoprost for eyes with OAG.

Financial Disclosure:

... receives consulting fees, retainer, or contract payments from a competing company, ... 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