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IOP and medication reduction after microinvasive glaucoma surgery (MIGS) with second-generation trabecular micro-bypass stents in subjects with open-angle glaucoma on one preoperative medication: 42 month outcomes

Poster Details

First Author: M.Töteberg-Harms SWITZERLAND

Co Author(s):                        

Abstract Details

Purpose:

The purpose of this study is to prospectively evaluate the long-term safety and IOP-lowering ability of two second-generation trabecular micro-bypass stents (iStent inject®) implanted as a standalone procedure in patients with OAG not controlled on one ocular hypotensive medication.

Setting:

The study was conducted by physicians of the MIGS study group. All surgeries and follow-up visits were completed at the S.V. Malayan Ophthalmological Center in Yerevan, Armenia.

Methods:

This is a prospective, single-arm study that enrolled 57 subjects with OAG not controlled on a single ocular hypotensive medication whose preoperative IOP was 18-30 mmHg (medicated) and 22-28 mmHg (after medication washout). All subjects underwent uncomplicated implantation of 2 iStent inject trabecular stents as a standalone procedure (ie, without concomitant cataract surgery). Assessments performed over the course of the study included IOP, medication burden, adverse events, BCVA, and findings from slit-lamp, gonioscopy, and fundus/optic nerve examinations.

Results:

All 57 subjects completed 42 months of follow-up. Preoperative medicated mean IOP was 19.5±1.5 mmHg and post-washout IOP was 24.4±1.3 mmHg. Postoperative mean IOP was ≤14.6mmHg at all study visits through 42 months. At 36 months postoperative, almost all subjects (95%) achieved both mean IOP ≤18 mmHg and IOP reduction of ≥20% on no medication compared to pre-op unmedicated IOP. All but 3 subjects remained ocular hypotensive medication-free. Post-op safety was excellent with only 2 AEs noted. One subject underwent trabeculectomy for elevated IOP and the other experienced progression of pre-existing cataract; both were unrelated to stent implantation.

Conclusions:

Long-term outcomes from this study demonstrate safe and sustained reduction of IOP to ≤15mmHg with elimination of medication in eyes with OAG following implantation of two iStent inject trabecular micro-bypass stents. This microinvasive technique may constitute a desirable alternative for patients with mild to moderate glaucoma and adds to the physician’s armamentarium of treatments.

Financial Disclosure:

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

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