Advances in Clinical and Experimental Medicine
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doi: 10.17219/acem/129576
Publication type: original article
Language: English
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Mid-term evaluation of the safety and efficacy of the iStent trabecular micro-bypass system combined with phacoemulsification
1 Department of Ophthalmology, Military Institute of Medicine, Warszawa, Poland
2 Department of Ophthalmology, Medical University of Białystok, Poland
Abstract
Background. Micro-invasive glaucoma surgery (MIGS) and MIGS devices have been gaining increasing attention in recent years. One such device is the trabecular micro-bypass stent, or iStent® (Glaukos Corporation, Laguna Hills, USA).
Objectives. To evaluate the safety and efficacy of the minimally invasive ab interno surgical implantation of a trabecular bypass during cataract surgery in reducing intraocular pressure (IOP) in patients with mild and moderate open-angle glaucoma and cataracts.
Material and Methods. The study was a prospective, uncontrolled, interventional case series (a prospective study of a case series), including 54 patients with a mean age of 72 years. All subjects underwent ab interno implantation of a single iStent together with cataract surgery. The corrected distance visual acuity (CDVA), IOP, anti-glaucoma medications, visual field, and number and type of complications were investigated after surgery. The patients were followed up at 1, 7, and 30 days, and 3, 6, 12, 24 and 36 months after the operation.
Results. The mean observation time was 20 months. At baseline, CDVA was 0.5 or better in 65% of the eyes; this improved to 0.5 or better in all eyes (0.8 or better in 79%) at the end of the observation. The mean baseline IOP was 17.1 mm Hg, which fell to a mean of 15.1 mm Hg. The mean number of medicinal eye drops prescribed preoperatively was 1.7, which decreased to 0.26 at the end of the observation.
Conclusion. Cataract surgery combined with iStent implantation seems to be an effective procedure in patients with mild to moderate open-angle glaucoma and cataracts. The insertion of 1 stent resulted in a significant decrease in IOP and a reduction in the number of topical anti-glaucoma medications needed. Based on the characteristics of the observed complications, iStent implantation can be considered a safe method.
Key words
open-angle primary glaucoma, micro-invasive glaucoma surgery, iStent®
References (18)
- Schmidt W, Kastner C, Sternberg K, et al. New concepts for glaucoma implants: Controlled aqueous humor drainage, encapsulation prevention and local drug delivery. Curr Pharm Biotechnol. 2013;14(1):98–111.
- Soltau JB, Rothmann RF, Budenzo DL, et al. Risk factors for glaucoma filtering bleb infections. Arch Ophthalmol. 2000;118(3):338–342.
- SooHoo JR, Seibold LK, Radcliffe NM, Kahook MY. Minimally invasive glaucoma surgery: Current implants and future innovations. Can J Ophthalmol. 2014;49(6):528–533.
- Saheb H, Ahmed II. Micro-invasive glaucoma surgery: Current perspectives and future directions. Curr Opin Ophthalmol. 2012;23(2):96–104.
- Neuhann TH. Trabecular micro-bypass stent implantation during small-incision cataract surgery for open-angle glaucoma or ocular hypertension: Long-term results. J Cataract Refract Surg. 2015;41(12):2664–2671.
- Fea AM, Consolandi G, Zola M, et al. Micro-bypass implantation for primary open-angle glaucoma combined with phacoemulsification: 4-year follow-up. J Ophthalmol. 2015;2015:795357.
- Arriola-Villalobos P, Martinez-de-la-Casa J, Diaz-Valle D, Fernández-Pérez C, García-Sánchez J, García-Feijoó J. Combined iStent trabecular micro-bypass stent implantation and phacoemulsification for coexistent open-angle glaucoma and cataract: A long-term study. Br J Ophthalmol. 2012;96(5):645–649.
- Belovay GW, Naqi A, Chan BJ, Rateb M, Ahmed IKK. Using multiple trabecular micro-bypass stents in cataract patients to treat open-angle glaucoma. J Cataract Refract Surg. 2012;38(11):1911–1917.
- Craven ER, Katz LJ, Wells JM, Giamporcaro JE; iStent Study Group. Cataract surgery with trabecular micro-bypass stent implantation in patients with mild-to-moderate open-angle glaucoma and cataract: Two-year follow-up. J Cataract Refract Surg. 2012;38(8):1339–1345.
- Fea AM. Phacoemulsification versus phacoemulsification with micro-bypass stent implantation in primary open-angle glaucoma: Randomized double-masked clinical trial. J Cataract Refract Surg. 2010;36(3):407–412.
- Samuelson TW, Katz LJ, Wells JM, Duh YJ, Giamporcaro JE; US iStent Study Group. Randomized evaluation of the trabecular micro-bypass stent with phacoemulsification in patients with glaucoma and cataract. Ophthalmology. 2011;118(3):459–467.
- Burian HM. A case of Marfan’s syndrome with bilateral glaucoma. With description of a new type of operation for developmental glaucoma (trabeculotomy ab externo). Am J Ophthalmol. 1960;50(6):1187–1192.
- Smith R. A new technique for opening the canal of Schlemm: Preliminary report. Br J Ophthalmol. 1960;44(6):370–373.
- Tanihara H, Negi A, Akimoto M, et al. Surgical effects of trabeculotomy ab externo on adult eyes with primary open angle glaucoma and pseudoexfoliation syndrome. Arch Ophthalmol. 1993;111(12):1653–1661.
- Heijl A, Leske MC, Bengtsson B, Hyman L, Bengtsson B, Hussein M; Early Manifest Glaucoma Trial Group. Reduction of intraocular pressure and glaucoma progression: Results from the early manifest glaucoma trial. Arch Ophthalmol. 2002;120(10):1268–1279.
- Ferguson TJ, Berdahl JP, Schweitzer JA, Sudhagoni RG. Clinical evaluation of a trabecular micro-bypass stent with phacoemulsification in patients with open-angle glaucoma and cataract. Clin Ophthalmol. 2016;10:1767–1773.
- Spiegel D, Wetzel W, Neuhann T, et al. Coexistent primary open-angle glaucoma and cataract: Interim analysis of a trabecular micro-bypass stent and concurrent cataract surgery. Eur J Ophthalmol. 2009;19(3):393–399.
- European Glaucoma Society. Terminology and Guidelines for Glaucoma. 4th ed. Savona, Italy: Dogma; 2014:1–191.




