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Two-Year Multicenter Outcomes of iStent inject Trabecular Micro-Bypass Stents Combined with Phacoemulsification in Various Types of Glaucoma and Ocular Hypertension

Authors Clement C, Howes F, Ioannidis AS, Shiu M, Manning D, Lusthaus J, Lim R, Skalicky SE, Goodwin T

Received 3 August 2020

Accepted for publication 15 October 2020

Published 28 October 2020 Volume 2020:14 Pages 3507—3517


Checked for plagiarism Yes

Review by Single anonymous peer review

Peer reviewer comments 3

Editor who approved publication: Dr Scott Fraser

Colin Clement, 1– 4 Frank Howes, 5 Alexandros S Ioannidis, 6 Michael Shiu, 7 David Manning, 8 Jed Lusthaus, 3, 4, 9 Ridia Lim, 3, 10 Simon E Skalicky, 11 Todd Goodwin 12

1Eye Associates, Sydney, NSW, Australia; 2Fairfield Eye Surgery, Fairfield, NSW, Australia; 3Glaucoma Unit, Sydney Eye Hospital, Sydney, NSW, Australia; 4Discipline of Ophthalmology, The University of Sydney, Sydney, NSW, Australia; 5Eye & Laser Centre, Gold Coast, QLD, Australia; 6Vision Eye Institute, Melbourne, VIC, Australia; 7Laser Sight Centre, Melbourne, VIC, Australia; 8Hunter Cataract & Eye Centre, Charlestown, NSW, Australia; 9Eyehaus, Sydney, NSW, Australia; 10Hunter St. Eye Specialists, Parramatta, NSW, Australia; 11Department of Surgery Ophthalmology, University of Melbourne, Melbourne, VIC, Australia; 12NQ Eye Specialists, Currajong, QLD, Australia

Correspondence: Colin Clement
Eye Associates, Level 4, 187 Macquarie Street, Sydney, NSW 2000, Australia
Tel +612 9247 9972

Purpose: This multicenter study evaluated 2-year effectiveness and safety following implantation of two second-generation trabecular micro-bypass stents (iStent inject®) with phacoemulsification.
Materials and Methods: This was a retrospective study of iStent inject implantation with phacoemulsification by nine surgeons across Australia. Eyes had mild to advanced glaucoma (predominantly primary open-angle/POAG, appositional angle-closure/ACG, or normal-tension/NTG) or ocular hypertension (OHT), and cataract. Evaluations included intraocular pressure (IOP); medications; proportions of eyes with 0 or ≥ 2 medications, reduced/stable medications versus preoperative, and IOP ≤ 15 mmHg; visual acuity; cup-to-disc ratio (CDR); visual fields (VF); adverse events; and secondary surgery.
Results: A total of 340 eyes underwent surgery and had 24-month follow-up data. At 24 months, mean IOP decreased by 16% from 16.4± 4.7 mmHg preoperatively to 13.7± 3.1 mmHg (p< 0.001), and 77% of eyes achieved IOP of ≤ 15 mmHg versus 49% preoperatively (p< 0.001). Mean number of medications decreased by 67% to 0.49± 0.95 versus 1.49± 1.20 preoperatively (p< 0.001), with 74% of eyes medication-free versus 25% preoperatively (p< 0.001), and 14% of eyes on ≥ 2 medications versus 46% preoperatively (p< 0.001). Medication burden was reduced or stable in 98% of eyes versus preoperative. Stratified analyses showed significant IOP and medication reductions across glaucoma subtypes (POAG, ACG, NTG, OHT): 13– 22% for IOP (p< 0.01 for all) and 62– 100% for medication (p< 0.001 for all). Favorable safety included few adverse events; stable CDR, VF, and visual acuity; and filtering surgery in only 8 eyes (2.4%) over 2 years.
Conclusion: This 340-eye multicenter dataset provides robust evidence of the safety and efficacy of iStent inject implantation with phacoemulsification, with significant and sustained IOP and medication reductions through 2 years. Results were similarly favorable across glaucoma subtypes (including POAG, ACG, NTG, OHT) and were attained across various glaucoma severities, clinical sites, and surgeons, highlighting the real-world versatility and utility of this treatment modality.

Keywords: microinvasive glaucoma surgery, MIGS, glaucoma, iStent inject, intraocular pressure, second-generation, multicenter

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