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Two-year results of a prospective, multicentre, randomised comparison of Hydrus vs two iStents in standalone surgery for open-angle glaucoma (COMPARE trial)

Poster Details

First Author: G.Gazzard UK

Co Author(s):                        

Abstract Details

Purpose:

The effectiveness of at least 3 different MIGS devices for reducing intraocular pressure (IOP) and medications when used in conjunction with cataract surgery has been demonstrated in large randomized studies. The purpose of this study was to compare the safety and effectiveness of 2 MIGS devices for IOP and hypotensive medication reduction as a standalone procedure without the confounding effect of cataract surgery.

Setting:

12 investigational centers located in the United Kingdom, Italy, Spain, Poland, Philippines, Mexico, Canada, Saudi Arabia, and Chile

Methods:

The study included 152 phakic and pseudophakic open angle glaucoma eyes controlled with ≥2 hypotensive medications and no prior incisional surgery. Stuey eyes were randomized in the operating room 1:1 for standalone surgery with either single Hydrus Microstent (Ivantis, Irvine, CA) or two GTS100 iStent Trabecular Micro-Bypass Stents (Glaukos Inc., San Clemente, CA). Comprehensive follow up ocular examinations including IOP and medication assessment were conducted at 1, 3, 6, 12, 18 and 24 months postoperatively.

Results:

75 eyes were randomized to HMS and 77 to 2iS. Preoperative IOPs were 19.0±3.9 and 19.1±3.6 mmHg and mean medication count 2.5±0.7 and 2.7±0.8 in the HMS and 2IS groups, respectively. At 24 months IOP in the HMS group was 17.6±3.5 and 18.8±4.0 in the 2IS group (p=0.058) and mean medications counts 1.2±1.2 (HMS) and 1.9±1.4 (2IS) (p=0.006).  For HMS 38% of eyes were medication free vs 18% for 2IS, (p=0.010). There were 0/75 (0%) secondary glaucoma surgeries in the HMS group and 7/77 (11%) in the 2IS group (p=0.013).

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 company producing, developing or supplying the product or procedure presented

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