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Study shows long-term safety, efficacy of iStent
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The implantation of a single trabecular microbypass stent provided stable, long-term IOP and medication reduction in a real-life cohort of eyes with a variety of glaucoma types and severity.
Sixty-five eyes of 43 patients with open-angle glaucoma and a mean age of 72.7 + 7.7 years were successfully and uneventfully implanted with the iStent (Glaukos Corp.) microbypass by a single surgeon in a private eye clinic in Munich, Germany.
Diagnoses included primary open-angle glaucoma, pseudoexfoliation glaucoma, secondary uveitic glaucoma, posttraumatic glaucoma as well as ocular hypertension. The degree of severity and optic nerve damage varied, with a predominance of more advanced cases. More than one-third of the eyes had previously undergone trabeculectomy or laser procedures, and more than two-thirds were on two or more medications. All eyes had visually significant cataract, and iStent implantation was combined with cataract surgery.
The long-term, 5-year follow-up showed stable decrease of IOP by 38% on average, with 92% of the eyes achieving an IOP of 18 mm Hg or lower, and 65% achieving an IOP of 15 mm Hg or lower. Medications were reduced by 75% to 0.5 vs. 2.0 preoperatively. The number of eyes on three to four medications decreased to 4% at 5 years vs. 28% preoperatively, and 69% of the patients became medication-free, “eliminating the cost, time and side effects associated with medication use,” the authors noted.
Over the duration of the follow-up, no severe device-related adverse event occurred.
This study provides some of the longest follow-up data currently published in the literature and proves the long-term efficacy and safety of the iStent implant in a heterogeneous patient population in a real-life clinical setting, the authors said.
“This realistic scenario makes the outcomes particularly relevant to practicing ophthalmologists who are evaluating surgical treatment options for their glaucoma patient population,” the authors wrote. – by Michela Cimberle
Disclosures: Neuhann conducts paid presentations for Staar Surgical Co. and Bausch + Lomb. Publication fees were paid by Glaukos Corp.
Perspective
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Carl H. Jacobsen, OD, FAAO
I love the minimally invasive glaucoma surgery (MIGS) concept. We need something to bridge the gap between topical/laser treatment and filtering surgery, and MIGS looks promising. The first implantable device, the iStent, has been available and in use since being FDA approved in 2012. How has this device worked for you?
I’ve been underwhelmed by its IOP-lowering ability and am unsure whether the modest IOP decrease postimplantation is due to the device or the cataract surgery itself. Neuhann and colleagues beg to differ.
This prospective, nonrandomized, consecutive case series found IOP 38% lower, on average, after iStent implantation. Furthermore, medications were decreased by 75%, from an average of 2.0 pre-iStent to 0.5 post-iStent. The stunning results of this study fly in the face of my personal experience, the experience of glaucoma specialists that I work with and the results of previous studies.
I’ll place my faith in a Cochrane review published last month that found, “There is very low-quality evidence that treatment with iStent may result in higher proportions of participants who are drop-free or achieving better IOP control.” I’ve not given up on MIGS, but I’m looking forward to more efficacious devices.
Reference:
Cochrane Database Syst Rev. 2019:March 28;3.
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