Posters

Three-year outcomes from prospective, randomized study of micro-invasive glaucoma surgery (MIGS) with two trabecular stents vs one prostaglandin in newly diagnosed open-angle glaucoma

Poster Details

First Author: G. Auffarth GERMANY

Co Author(s):                        

Abstract Details

Purpose:

Recent findings by the Micro-Invasive Glaucoma Surgery (MIGS) Study Group showed IOP control through 2 years following treatment with either 2 trabecular bypass stents or medical therapy in a prospective, randomized controlled study in patients with newly diagnosed glaucoma naïve to treatment. This work provides follow-up data through 3 years in the same set of study subjects.

Setting:

The MIGS Study Group consists of visiting surgeons and staff surgeons from eight countries worldwide. Surgeons have performed MIGS procedures at one investigational setting – the S.V. Malayan Ophthalmological Center in Yerevan, Armenia.

Methods:

Study qualification criteria included IOP ≥ 21 mmHg and ≤ 40mmHg, and CD ratio ≤ 0.9. Eyes were randomized 1:1 to either implantation of two trabecular stents (iStent® Trabecular Micro-Bypass, Glaukos Corporation; n = 54) or to administration of travoprost (n=48). Following treatment, medication was to be added to study eyes in either group for elevated IOP (e.g., IOP > 21 mmHg) or for optic nerve findings. Clinical parameters before treatment and through up to 5 years post-treatment included IOP, medication use, treatment and post-treatment complications, BCVA, slit-lamp exam, fundus/optic nerve exam, gonioscopy, visual field and CD ratio.

Results:

In stent-implanted eyes, IOP reduced from 25.5 mmHg preoperatively to 14.6 mmHg at 3 years. No complications were reported during implantation of stents. In travoprost-treated eyes, IOP decreased from 25.0 mmHg before treatment to 15.3 mmHg at 3 years. By the 3-year exam, 6 stent eyes and 11 travoprost eyes in had medical therapy added to their original treatment. Over the 3-year follow-up period, progression of cataract was observed in 11 stent-implanted eyes and 8 travoprost-treated eyes, with cataract surgery performed in 5 stent eyes and 1 travoprost eye. No other post-treatment adverse events were reported.BCVA appeared stable over time.

Conclusions:

Follow-up data through 3 years from a prospective, randomized study to treat newly diagnosed OAG with either implantation of 2 trabecular micro-bypass stents or travoprost showed substantial decrease in IOP in both groups. These data suggest that 2 trabecular stents or prostaglandin offer IOP control with a favorable safety profile through 3 years in this patient population.

Financial Disclosure:

One or more of the authors research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented