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Prospective Evaluation of Two iStent® Trabecular Stents, One iStent Supra® Suprachoroidal Stent, and Postoperative Prostaglandin in Refractory Glaucoma: 4-year Outcomes

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Myers, Jonathan S. and Masood, Imran and Hornbeak, Dana M. and Belda Sanchís, Jose I. and Auffarth, Gerg and Jünemann, Anselm and Giamporcaro, Jane Ellen and Martínez de la Casa, Jose Maria and Ahmed, Iqbal Ike K. and Voskanyan, Lilit and Katz, L. Jay (2018) Prospective Evaluation of Two iStent® Trabecular Stents, One iStent Supra® Suprachoroidal Stent, and Postoperative Prostaglandin in Refractory Glaucoma: 4-year Outcomes. Advances in Therapy, 35 (3). pp. 395-407. ISSN 0741-238X

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Official URL: https://doi.org/10.1007/s12325-018-0666-4




Abstract

Introduction: This study evaluates long-term outcomes of two trabecular micro-bypass stents, one suprachoroidal stent, and postoperative prostaglandin in eyes with refractory open angle glaucoma (OAG).
Methods: Prospective ongoing 5-year study of 80 eligible subjects (70 with 4-year follow-up) with OAG and IOP ≥ 18 mmHg after prior trabeculectomy and while taking 1–3 glaucoma medications. Subjects received two iStent® trabecular micro-bypass stents, one iStent Supra® suprachoroidal stent, and postoperative travoprost. Postoperative IOP was measured with medication and annually following medication washouts. Performance was measured by the proportion of eyes with ≥ 20% IOP reduction on one medication (the protocol-specified prostaglandin) versus preoperative medicated IOP (primary outcome); and the proportion of eyes with postoperative IOP ≤ 15 and ≤ 18 mmHg on one medication (secondary outcome). Additional clinical and safety data included medications, visual field, pachymetry, gonioscopy, adverse events, visual acuity, and slit-lamp and fundus examinations.
Results: Preoperatively, mean medicated IOP was 22.0 ± 3.1 mmHg on 1.2 ± 0.4 medications, and mean unmedicated IOP was 26.4 ± 2.4 mmHg. Postoperatively, among eyes without later cataract surgery, mean medicated IOP at all visits through 48 months was ≤ 13.7 mmHg (≥ 37% reduction), and annual unmedicated IOP was ≤ 18.4 mmHg (reductions of ≥ 30% vs. preoperative unmedicated IOP and ≥ 16% vs. preoperative medicated IOP). At all postoperative visits among eyes without additional surgery or medication, ≥ 91% of eyes had ≥ 20% IOP reduction on one medication versus preoperative medicated IOP. At month 48, 97 and 98% of eyes achieved IOP ≤ 15 and ≤ 18 mmHg, respectively, on one medication. Six eyes required additional medication, no eyes required additional glaucoma surgery, and safety measurements were favorable throughout follow-up.
Conclusion: IOP control was achieved safely with two trabecular micro-bypass stents, one suprachoroidal stent, and postoperative prostaglandin. This microinvasive, ab interno approach introduces a possible new treatment option for refractory disease.
Trial Registration: NCT01456390.
Funding: Glaukos Corporation.


Item Type:Article
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Received: November 2, 2017 / Published online: February 23, 2018
The Author(s) 2018. This article is an open access publication

To view enhanced content for this article go to: https://doi.org/10.6084/m9.figshare.5809359.

The online version of this article ( https://doi.org/10.1007/s12325-018-0666-4) contains supplementary material, which is available to authorized users.

Uncontrolled Keywords:Glaucoma; iStent; iStent Supra; Microinvasive glaucoma surgery (MIGS); Ophthalmology; Prostaglandin; Refractory glaucoma; Suprachoroidal; Trabecular
Subjects:Medical sciences > Medicine > Surgery
Medical sciences > Medicine > Ophtalmology
ID Code:47059
Deposited On:06 Apr 2018 08:11
Last Modified:06 Apr 2018 11:04

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