Posters

24 month results from a prospective multicenter randomised study of a Schlemm’s canal microstent for reduction of IOP in primary open-angle glaucoma: The HORIZON Trial

Poster Details

First Author: S.Lim UK

Co Author(s):                        

Abstract Details

Purpose:

To evaluate the safety and effectiveness of a new Schlemm’s canal microstent to lower diurnal IOP and medication use in patients with primary open angle glaucoma (POAG) and cataract

Setting:

HORIZON is a prospective, multicenter, randomized, controlled clinical trial comparing concurrent phacoemulsification with a Schlemm’s canal microstent (Hydrus Microstent, Ivantis Inc, Irvine, CA) to phacoemulsification alone. The study recruited 556 volunteers from 38 clinical practices located in 12 countries in Europe, UK, North America, Asia with POAG and cataract

Methods:

Prior written informed consent was obtained for all study subjects. Key inclusion criteria were mild to moderate POAG treated with 1-4 topical hypotensive medications, age related cataract, and washed out diurnal IOP (DIOP) of 22-34 mmHg. Prior glaucoma surgery in the study eye was excluded. Following successful phacoemulsification, eyes randomized 2:1 into Hydrus Microstent (HMS) or no stent (NS) groups. Postoperative follow-up was completed through 24 months. Medication wash out was repeated at 12 and 24 months and DIOP measured in order to assess treatment effect without the confounding influence of topical hypotensive medications

Results:

556 eyes were randomized to HMS (N=369) or NS (N=187). There were no differences in baseline characteristics. Preoperative DIOP was 25.5±3.0 mmHg (HMS) and 25.4±2.9 mmHg (NS). At 24 months, mean reduction in DIOP was -7.5±4.1 mmHg (HMS) and -5.2±3.9 mmHg (NS), difference in change = -2.3 mmHg, 95% CI -3.0 to -1.6, p<0.001. Complete elimination of medication was 78% (HMS) vs. 48% (NS), difference = 30%, p<0.001. Follow up BCVA and VF changes were equivalent. There was a significantly higher rate of IOP related adverse events (rescue surgery, IOP spikes, hypotony) in the NS group

Conclusions:

This study demonstrated that concurrent Schlemm’s canal stenting in patients undergoing cataract surgery is safe and effective in lowering IOP and medication use compared to cataract surgery alone at 24 months

Financial Disclosure:

receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented, research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented