Posters

Long-term IOP control with one, two, or three trabecular micro-bypass stents for OAG: 54 month outcomes

Poster Details

First Author: A.Carceller Guillamet SPAIN

Co Author(s):                        

Abstract Details

Purpose:

This study assessed IOP- and medication- reducing effects and safety of 1, 2, or 3 trabecular micro-bypass stents (iStent®) implanted as a standalone procedure in eyes with open-angle glaucoma (OAG) on topical glaucoma medication(s). Previously published reports show favorable outcomes and incremental benefits of multiple iStent devices.

Setting:

Participating surgeons in this study included five visiting MIGS Study Group surgeons from four countries (USA, Italy, Germany, and Spain), in addition to one staff surgeon (Armenia). All surgeries and follow-up visits were completed at the S.V. Malayan Ophthalmological Center in Yerevan, Armenia.

Methods:

Subjects with OAG on 1 to 3 ocular hypotensive medications were enrolled in this prospective, randomized study. Inclusion criteria included preoperative IOP of 18-30 mmHg on medication and 22-38 mmHg following medication washout. Subjects were randomized (1:1:1) to 1, 2, or 3 trabecular micro-bypass stents implanted as a standalone procedure. Annual medication washouts were performed to assess unmedicated IOP. Postoperative ocular hypotensive medications were started in cases of elevated IOP and/or optic nerve change. The study assessed IOP, medication use, BCVA, slit-lamp examination, gonioscopy findings, fundus/optic nerve evaluation, and adverse events.

Results:

Subjects were randomized to 1 stent (n=38), 2 stents (n=41), and 3 stents (n=40). Preoperative mean medicated IOP (19.8, 20.1, 20.4 mmHg) and post-washout IOP (25.0, 25.0, and 24.9 mmHg) were similar amongst the 1-, 2-, and 3-stent groups, respectively. At all postoperative visits through 54 months, mean medicated IOP was 17.1 mmHg or lower for all groups. Over 54 months, more eyes in the multiple stents groups remained medication-free. Safety was favorable with no operative complications. At month 54, 2 eyes in the 1-stent group underwent trabeculectomy due to glaucoma progression and not related to stent implantation.

Conclusions:

Outcomes through 54 months following single- or multiple-stent implantation as a standalone procedure demonstrated substantial IOP reduction, reduced medication burden, and an overall favorable safety profile in patients with OAG not controlled on medications. The study demonstrated incrementally greater IOP reduction with more eyes remaining medication-free in the multiple-stents groups.

Financial Disclosure:

None