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

Colin Clement; Frank Howes; Alexandros S Ioannidis; Michael Shiu; David Manning; Jed Lusthaus; Ridia Lim; Simon E Skalicky; Todd Goodwin

doi:10.2147/OPTH.S271646

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

Clin Ophthalmol. 2020 Oct 28:14:3507-3517. doi: 10.2147/OPTH.S271646. eCollection 2020.

Authors

Colin Clement^{1

2

3

4}, Frank Howes⁵, Alexandros S Ioannidis⁶, Michael Shiu⁷, David Manning⁸, Jed Lusthaus^{3

4

9}, Ridia Lim^{3

10}, Simon E Skalicky¹¹, Todd Goodwin¹²

Affiliations

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

Abstract

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: MIGS; glaucoma; iStent inject; intraocular pressure; microinvasive glaucoma surgery; multicenter; second-generation.