3-year safety and efficacy outcomes from an international, prospective, multicentre and randomised study of a Schlemm’s canal microstent (HORIZON trial)

Session Details

Session Title: Microinvasive Glaucoma Surgery

Session Date/Time: Sunday 15/09/2019 | 14:00-16:00

Paper Time: 15:18

Venue: Free Paper Forum: Podium 4

First Author: : G.Gazzard UK

Co Author(s): :                                 

Abstract Details

Purpose:

To assess long term IOP, medication reduction, and safety outcomes after combination cataract surgery with the Hydrus Microstent compared to cataract surgery only in patients with mild to moderate primary open angle glaucoma.

Setting:

36 investigational centers located in the United States, United Kingdom, Germany, Italy, Spain, Poland, Philippines, Mexico and Canada

Methods:

Eyes with visual field mean deviation 0 to -12dB taking 1-4 hypotensive medications and preoperative washed out diurnal IOP (DIOP) 22-34 mmHg were randomized in the operating room 2:1 to have cataract surgery with a Schlemm’s canal microstent (HMS) or cataract surgery alone (CS). Patients were followed for 36 months postoperatively. Procedure effectiveness was assessed by comparing changes in intraocular pressure (IOP) and medication use. Safety metrics included visual acuity (VA) changes, visual field progression, ocular health, and corneal endothelial cell counts.

Results:

369 eyes were randomized to HMS and 187 to CS. Preoperative IOP was 18.0 ± 3.1 mmHg on 1.7 ± 1.0 glaucoma medications in both groups. Medication count decreased 1.3 ± 0.8 mmHg in HMS and 0.9±1.0 mmHg in the CS group (p<0.001). From 1 week to 36 months, VA was equivalent between groups. At 36 months, central endothelial cell loss was -15% in the HMS group vs. -11% in the CS group (p=ns). Composite IOP related events (filtration surgery, IOP spike after 30 days, or hypotony) were higher in the CS group (1.3% vs. 6.5%, p=0.011).

Conclusions:

Combined cataract surgery with Hydrus microstent significantly reduced IOP and the frequency of IOP related events through 36 months. There were no significant differences in visual acuity, % central endothelial cell loss, or other safety measures between groups at 36 months.

Financial Disclosure:

receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented, travel has been funded, fully or partially, by a competing company, travel has been funded, fully or partially, by a company producing, developing or supplying the product or procedure presented, research is funded, fully or partially, by a competing company, receives non monetary benefits from a competing company, receives consulting fees, retainer, or contract payments from a competing company