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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. y Masood, Imran y Hornbeak, Dana M. y Belda Sanchís, Jose I. y Auffarth, Gerg y Jünemann, Anselm y Giamporcaro, Jane Ellen y Martínez de la Casa, Jose Maria y Ahmed, Iqbal Ike K. y Voskanyan, Lilit y 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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URL Oficial: https://doi.org/10.1007/s12325-018-0666-4




Resumen

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.


Tipo de documento:Artículo
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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.

Palabras clave:Glaucoma; iStent; iStent Supra; Microinvasive glaucoma surgery (MIGS); Ophthalmology; Prostaglandin; Refractory glaucoma; Suprachoroidal; Trabecular
Materias:Ciencias Biomédicas > Medicina > Cirugía
Ciencias Biomédicas > Medicina > Oftalmología
Código ID:47059
Depositado:06 Abr 2018 08:11
Última Modificación:06 Abr 2018 11:04

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