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Paired eye comparison of IOP reduction between Hydrus and iStent Inject in bilateral combination cataract surgery in routine clinical practice

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First Author: P.Turgeon USA

Co Author(s):    N. Turgeon                    

Abstract Details

Purpose:

Two different Schlemm’s canal based minimally invasive glaucoma surgery (MIGS) stents were recently approved by the US FDA and are commercially distributed in the United States. Both devices demonstrated the ability to lower IOP compared to cataract surgery alone at 2 years in separate randomized clinical trials. The purpose of this evaluation is to provide a direct head-to-head comparison of the IOP lowering capability of the devices when combined with cataract surgery in a matched population.

Setting:

Study subjects were drawn from a single clinical practice located in the United States and all procedures performed by a single surgeon. The use of both devices was consistent with product labeling approved by the US FDA.

Methods:

Patients with bilateral age-related cataract and mild to moderate primary open angle glaucoma were included in the study. Eyes with other significant ocular comorbidities or prior glaucoma surgery were excluded. The first eye was treated with either the Hydrus (HS) or iStent Inject (IS) after successful cataract surgery, followed by treatment in fellow eye with the opposite device. IOP, glaucoma medication, visual acuity data was collected postoperatively at 1, 3, 6, and 12 months. The change in IOP from preoperative was calculated for each eye. The mean between eye difference in IOP was evaluated using a 2-sided paired t-test.

Results:

56 eyes from 28 patients were treated. Mean age was 72.9±5.3 years, 96% were Caucasian, and 61% were male. In HS and IS groups, mean preoperative IOP (mmHg) was 18.9±4.1 and 17.9±4.3 (p=0.35) and preoperative medications were 1.5±1.0 and 1.5±1.0 (p=0.89). Through 3 months, medications were reduced by -0.7±0.9 and -0.8±1.0 (p=0.75) and IOP by -4.0±4.5 mmHg and -2.3±3.7 in the HS and IS groups respectively. The mean paired eye difference was -1.7 mmHg (95% CI = -3.1 to -0.3; p=0.019). There were no differences in postoperative visual acuity or safety.

Conclusions:

In a paired eye comparison of two Schlemm’s canal based MIGS stents used in paired eyes with equivalent preoperative IOP, medication count, and glaucoma, the Hydrus provided significantly greater IOP reduction at 3-months follow up compared to iStent Inject when combined with cataract surgery. Financial Disclosure: the author has no financial interest in either Ivantis, Inc or Glaukos, Inc.

Financial Disclosure:

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