Outcomes Following Implantation of Two Second-Generation Trabecular Micro-Bypass Stents in Patients with Open-Angle Glaucoma on One Medication: 18-Month Follow-Up

Richard Lindstrom, Richard Lewis, Dana M Hornbeak, Lilit Voskanyan, Jane Ellen Giamporcaro, John Hovanesian, Steven Sarkisian, Richard Lindstrom, Richard Lewis, Dana M Hornbeak, Lilit Voskanyan, Jane Ellen Giamporcaro, John Hovanesian, Steven Sarkisian

Abstract

Introduction: The study objective was to evaluate the intraocular pressure (IOP) and medication-lowering effect of 2 second-generation trabecular micro-bypass stents in eyes with open-angle glaucoma (OAG) on one preoperative medication.

Methods: Fifty-seven qualified phakic eyes with OAG on 1 medication, preoperative medicated IOP of 18-30 mmHg, and preoperative unmedicated (post-washout) IOP of 22-38 mmHg underwent implantation of 2 second-generation trabecular micro-bypass stents in a standalone procedure. Evaluations included IOP, best-corrected visual acuity, medication use, fundus and slit lamp examinations, visual field, cup to disc ratio, pachymetry, and complications and interventions. Subjects have been followed for 18 months, and follow-up is ongoing.

Results: At Month 12 postoperative, 100% of eyes had achieved an IOP reduction ≥20% (100% had IOP ≤18 mmHg and 67% had IOP ≤15 mmHg) without medication versus preoperative unmedicated IOP, and 75% had IOP reduction ≥20% without medication versus preoperative medicated IOP. The Month 12 mean unmedicated IOP had decreased by 42%, to 14.2 ± 1.9 mmHg vs 24.4 ± 1.3 mmHg preoperatively, and this reduction was maintained through 18 months (14.4 ± 2.1 mmHg). A high safety profile was observed.

Conclusion: In this prospective, open-label, single-arm study, the standalone implantation of two second-generation trabecular micro-bypass stents in OAG patients on 1 preoperative medication resulted in IOP reduction to ≤15 mmHg and elimination of medication through 18 months, with favorable safety.

Trial registration: ClinicalTrials.gov identifier, NCT02868190.

Funding: Glaukos Corporation, San Clemente, CA.

Keywords: Glaucoma; IOP; MIGS; Medication; Ophthalmology; Trabecular micro-bypass.

Figures

Fig. 1
Fig. 1
The iStent inject and iStent inject trabecular micro-bypass stent system
Fig. 2
Fig. 2
Proportional analysis of Month 12 intraocular pressure (IOP) (N = 57). M month
Fig. 3
Fig. 3
Mean intraocular pressure (IOP) over time (N = 57). BL baseline, M month, PRE preoperative
Fig. 4
Fig. 4
Preoperative and Month 18 best-corrected visual acuity (BCVA) (N = 57). M month, PRE preoperative

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