36 month results from a multicenter randomised study of a Schlemm’s canal microstent for reduction of IOP in primary open-angle glaucoma: the HYDRUS II trial

Session Details

Session Title: Glaucoma & Posterior Segment

Session Date/Time: Monday 24/09/2018 | 08:00-10:30

Paper Time: 08:18

Venue: Room A3, Podium 1

First Author: : A.Fea ITALY

Co Author(s): :    N. Pfeiffer   J. Garcia-Fijo   S. Gandolfi   H. Lemij   L. Au        

Abstract Details

Purpose:

A significant reduction in mean IOP and medication count in the microstent treatment group compared to cataract surgery alone at 24 months was reported previously. This study evaluated the effectiveness of a Schlemm’s canal microstent to lower diurnal IOP and medication use in patients with primary open angle glaucoma (POAG) and cataract at 36 months postoperative. Medication wash out and diurnal IOP assessment was utilized n order to assess device effectiveness without the confounding effect of hypotensive medications.

Setting:

HYDRUS II 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 subjects from 7 clinical practices located in Germany, Italy, Spain and The The Netherlands with POAG and cataract.

Methods:

Key inclusion criteria were mild to moderate OAG, age related cataract, and washed out diurnal IOP (DIOP) of 21-36 mmHg. Prior glaucoma surgery in the study eye was excluded. Following successful phacoemulsification, eyes were randomized 1:1 to receive the Hydrus Microstent (HMS) or no stent (NS). Medication wash out and diurnal IOP assessment was repeated at 36 months using Goldmann applanation tonometry.

Results:

100 eyes were randomized to HMS (N=50) or NS (N=50) at the time of surgery. 45 HMS eyes and 44 NS eyes completed 36-month follow up. Preoperative medicated IOP was 18.9± 3.3 mmHg (HMS) and 18.6 ± 3.8 mmHg (NS); preoperative medication count was 2.0±1.0 in both groups. After medication wash out baseline DIOP was 26.2±4.4 mmHg (HMS) and 26.8±4.3 mmHg (NS). Prior to 36M wash out, mean medications count was 0.7±1.0 (HMS) and 1.3±1.1 (NS) (p=0.021). After medication wash out, DIOP was 18.3±4 mmHg (HMS) and 20.6±5.3 mmHg (NS) (p=0.034).

Conclusions:

This prospective, multicenter, controlled, randomized trial demonstrated that concurrent Schlemm’s canal stenting in eyes undergoing cataract surgery is effective in significantly lowering IOP and medication use compared to cataract surgery alone at 36 months.

Financial Disclosure:

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