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

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

Colin Clement  1   2   3   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
Affiliations

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

Colin Clement et al. Clin Ophthalmol. .

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.

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Conflict of interest statement

CC reports personal fees from Allergan, Glaukos, Alcon, Merck, Sharp, Dohme. FH reports personal fees from Glaukos. ASI is a consultant for Glaukos. DM reports personal fees from Glaukos, Allergan, and Alcon including being a consultant for Alcon. JL reports research grants from Sydney Eye Hospital Foundation, Glaukos, and Zeiss. RL reports personal fees from Allergan and is a consultant for Glaukos. SS reports honoraria as a consultant from Glaukos. TG reports personal fees from and serves in the advisory board for Glaukos. The authors report no other conflicts of interest in this work.

Figures

Figure 1
Figure 1
Mean IOP through 24 months postoperative, all eyes (n=340).
Figure 2
Figure 2
Proportional analysis of IOP at 24 months vs preoperative, all eyes (n=340).
Figure 3
Figure 3
Mean number of medications through 24 months postoperative, all eyes (n=340).
Figure 4
Figure 4
Proportional analysis of medications at 24 months vs preoperative, all eyes (n=340).
Figure 5
Figure 5
IOP reduction by glaucoma subtype (p<0.01 for all).
Figure 6
Figure 6
Medication reduction by glaucoma subtype (p<0.001 for all).
See this image and copyright information in PMC

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