Four-Year Outcomes of Two Second-Generation Trabecular Micro-Bypass Stents in Patients with Open-Angle Glaucoma on One Medication

Richard Lindstrom, Steven R Sarkisian, Richard Lewis, John Hovanesian, Lilit Voskanyan, Richard Lindstrom, Steven R Sarkisian, Richard Lewis, John Hovanesian, Lilit Voskanyan

Abstract

Introduction: This study evaluated long-term reductions in intraocular pressure (IOP) and medication following implantation of 2 second-generation trabecular micro-bypass stents (iStent inject®) in eyes with open-angle glaucoma (OAG) not controlled on 1 preoperative medication.

Material and methods: In this prospective interventional multi-surgeon study, standalone implantation of 2 iStent inject stents was performed in 57 eyes of 57 subjects with OAG, preoperative IOP of 18-30 mmHg on 1 medication, and preoperative post-washout IOP of 22-38 mmHg. The main outcome measures included the proportions of eyes achieving medication-free IOP ≤18 mmHg, IOP ≤15 mmHg, or ≥20% IOP reduction versus preoperative unmedicated IOP. Assessments included IOP, medications, visual acuity, visual field, pachymetry, complications, and interventions. Subjects were followed for 48 months with follow-up continuing in all eyes.

Results: At Month 48 (n=57), 95% of eyes achieved an IOP reduction of ≥20% without medication versus preoperative washout IOP; and although they had eliminated medication, 81% of eyes still had an IOP reduction of ≥20% versus preoperative IOP on 1 medication. Mean 48-month unmedicated IOP decreased by 46% to 13.2±1.6 mmHg vs 24.4±1.3 mmHg preoperatively (p<0.0001), with 95% of medication-free eyes having IOP ≤18mmHg and 82% having IOP ≤15mmHg. Over the course of follow-up, 3 eyes had medication added and 1 eye underwent a secondary glaucoma surgery, and safety parameters were favorable.

Discussion: Standalone iStent inject implantation in OAG patients on 1 preoperative medication resulted in average IOP reduction to ≤15 mmHg with the elimination of medication and favorable safety through 48 months.

Trial registration: ClinicalTrials.gov identifier, NCT02868190.

Keywords: MIGS; glaucoma; iStent inject; prostaglandin; second-generation; trabecular micro-bypass.

Conflict of interest statement

R. Lindstrom reports personal fees, non-financial support from Glaukos Corporation, during the conduct of the study. R. Lewis is consultant for Allergan, Alcon, AVS, ELTSight, Equinox, Glaukos, Ivantis, Kedalion, SimpleContacts, ViaLase, and Zeiss; Chief Medical Officer for Aerie. He reports grants from Glaukos, during the conduct of the study; grants from Ivantis, Glaukos, ELT Sight, Alcon, New World Medical, Equinox, Aerie Pharmaceuticals, MicroOptyx, and Sanoculis, outside the submitted work. S.R. Sarkisian reports grants, lecture fees from and is consultant for Alcon Laboratories, Inc. He is consultant for and received lecture fees from Allergan. He is also consultant for Beaver-Visitec International, Inc., Katena Products, Inc., New World Medical Inc., Santen, Inc., Omeros, Glaukos Corporation, Bausch & Lomb, and Sight Sciences, Inc. He received grant from and is equity owner of Sight Sciences, Inc. He also received grants from Glaukos Corporation and Bausch & Lomb, outside the submitted work. L. Voskanyan received financial support from Glaukos for her work as an investigator in this study. J. Hovanesian is a consultant to and a stockholder of Glaukos. The authors report no other conflicts of interest in this work.

© 2020 Lindstrom et al.

Figures

Figure 1
Figure 1
iStent inject® trabecular micro-bypass stent system: stents and injector.
Figure 2
Figure 2
Mean intraocular pressure through 48 months postoperative.a,b Notes:aVertical bars represent standard deviation. bEyes with secondary surgery or addition of medication were counted as non-responders, and their subsequent IOP data were excluded from mean IOP calculation. cUnmedicated/Post-washout. A 1-month medication washout was completed preoperatively. Abbreviations: SCR, Screening; BL, Baseline; M, Month; IOP, intraocular pressure; Preop, preoperative; Med, medication.
Figure 3
Figure 3
Proportional Analysis of Medication-Free IOP and IOP Reduction at 12 and 48 Months Postoperative (n=57 for each category at both time points).a Note:aEyes with secondary surgery or addition of medication were counted as non-responders. Abbreviations: IOP, intraocular pressure; SCR, Screening; BL, Baseline; M, Month; Preop, preoperative; Med, medication.

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