Posters

Initial U.S. experience with iStent inject® trabecular micro-bypass implantation with cataract surgery

Poster Details

First Author: B.Williamson USA

Co Author(s):                        

Abstract Details

Purpose:

This study evaluates early U.S. experience with 2 nd -generation trabecular micro-bypass stents (iStent inject®) implanted in combination with cataract surgery as treatment for primary open-angle glaucoma (POAG) and cataract.

Setting:

Private ophthalmology center in Louisiana, USA.

Methods:

This consecutive case series evaluates performance and safety in eyes with predominantly mild-to-moderate POAG that underwent iStent inject implantation with cataract surgery. The dataset comprises 76 eyes (mean VF MD -5.6 dB, C/D ratio 0.6), with a subset followed to 1 year postoperative. Given early usage of the device in the U.S., shorter-term outcomes are currently available, but follow-up is ongoing and more complete data will be presented at the congress. Efficacy measures included mean intraocular pressure (IOP), mean number of medications, and proportional analyses of IOP and medication burden. Safety outcomes included adverse events and secondary surgeries.

Results:

Preoperatively, mean IOP was 21.6±3.0mmHg on 1.5±0.9 medications (n=76). Through 12 months postoperative, mean IOP reduced 21-28%: to 16.1±3.2mmHg at Month 1 (M1, n=54), 15.5±3.7mmHg at M3 (n=26), 17.0±2.3mmHg at M6 (n=12), and 16.9±3.4mmHg at M12 (n=9)(p<0.001 vs preoperative throughout). Postoperative mean number of medications reduced to 0.8±0.9 at M3 (n=25), 1.0±1.2 at M6 (n=12), and 0.2±0.4 at M12 (n=9)(p<0.05 throughout). At last follow-up (average ~10 weeks, range 4-52 weeks), 41% of eyes were medication-free (vs 1% preoperatively); 84% of eyes had IOP ≤18mmHg (vs 18% preoperatively); and 43% had IOP ≤15mmHg (vs 1% preoperatively). Safety was favorable throughout.

Conclusions:

This real-world study provides early evidence of favorable outcomes with iStent inject implanted with cataract surgery. iStent inject trabecular micro-bypass resulted in statistically and clinically meaningful IOP and medication reduction with a high safety profile, consistent with the existing clinical evidence on the device.

Financial Disclosure:

None