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. 2020 Aug;46(8):1172-1177.
doi: 10.1097/j.jcrs.0000000000000286.

Twelve-month outcomes of an ab interno gelatin stent combined with cataract surgery or as a standalone procedure in pseudophakic eyes with open-angle glaucoma

Affiliations

Twelve-month outcomes of an ab interno gelatin stent combined with cataract surgery or as a standalone procedure in pseudophakic eyes with open-angle glaucoma

Peyton A Rather et al. J Cataract Refract Surg. 2020 Aug.

Abstract

Purpose: To provide safety and effectiveness outcomes at 12 months postsurgery for an ab interno transscleral gelatin stent in patients with advanced refractory glaucoma or intolerant of medical therapy.

Setting: Multisubspecialty ophthalmology practice and surgery center.

Design: Retrospective, single-arm, cohort study.

Methods: All patients implanted with the gelatin stent either combined with cataract surgery or as a solo procedure between February 2017 and April 2018 and meeting eligibility criteria were included. Outcome measures included proportion of patients achieving a 20% reduction in intraocular pressure (IOP), proportions at or below 12 mm Hg, 15 mm Hg, and 18 mm Hg, IOP, medication usage, needling rate, and adverse events.

Results: The study included 92 eyes of 69 patients. Mean preoperative IOP and medications were 16.6 mm Hg on 2.1 medications. Average visual field mean deviation was -13.7 dB. Half (48%) of the patients achieved the primary endpoint of 20% reduction while medication use decreased by -1.7 medications. Most patients at 12 months had IOP of 18 mm Hg or less on zero medications (74%), whereas 34% were medication free and had IOP of 12 mm Hg or less. Bleb needling was required for only 14% of patients. There were few adverse events (13% of eyes), the most common being corrected distance visual acuity loss and hyphema.

Conclusions: Eyes with advanced glaucoma despite maximum tolerated medical therapy achieved lower target IOP on fewer medications after implantation with the gelatin microstent.

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References

    1. Grover DS, Flynn WJ, Bashford KP, Lewis RA, Duh YJ, Nangia RS, Niksch B. Performance and safety of a new ab interno gelatin stent in refractory glaucoma at 12 months. Am J Ophthalmol 2017;183:25–36
    1. United States Food and Drug Administration. Guidance for Industry. Aqueous shunts–510(k) submissions. Rockville, MD: US Department of Health and Human Services; 1998
    1. United States Food and Drug Administration. Guidance for Industry. Premarket studies of implantable minimally invasive glaucoma surgical (MIGS) devices. Rockville, MD: US Department of Health and Human Services; 2015
    1. Samuelson TW, Sarkisian SR, Lubeck DM, Stiles MC, Duh YJ, Romo EA, Giamporcaro JE, Hornbeak DM, Katz LJ. Prospective, randomized, controlled pivotal trial of an ab interno implanted trabecular micro-bypass in primary open-angle glaucoma and cataract. Ophthalmology 2019;126:811–821
    1. Samuelson TW, Chang DF, Marquis R, Flowers B, Lim KS, Ahmed IIK, Jampel HD, Aung T, Crandall AS, Singh K. A Schlemm canal microstent for intraocular pressure reduction in primary open-angle glaucoma and cataract. Ophthalmology 2019;126:29–37