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360° ab-interno trabeculotomy in refractory primary open-angle glaucoma

Authors Sarkisian SR, Mathews B, Ding K, Patel A, Nicek Z

Received 30 September 2018

Accepted for publication 24 November 2018

Published 11 January 2019 Volume 2019:13 Pages 161—168


Checked for plagiarism Yes

Review by Single anonymous peer review

Peer reviewer comments 2

Editor who approved publication: Dr Scott Fraser

Steven R Sarkisian,1 Basil Mathews,2 Kai Ding,2 Aashka Patel,2 Zachary Nicek2

1University of Oklahoma College of Medicine, Dean McGee Eye Institute, Oklahoma City, OK, USA; 2University of Oklahoma, Oklahoma City, OK, USA

Purpose: The purpose of this study was to evaluate the safety and efficacy of microinvasive glaucoma surgery (MIGS) with 360° ab-interno trabeculotomy using the TRAB360 device as a stand-alone procedure in patients with refractory primary open-angle glaucoma (POAG) and preoperative IOP ≥18 mmHg.
Setting: This study evaluated patients treated in a tertiary-referral clinical practice setting.
Design: This study is a retrospective analysis of 81 eyes.
Methods: Patients with refractory open-angle glaucoma underwent stand-alone 360° ab-interno trabeculotomy using the TRAB360 device. Effectiveness was determined by reduction in medicated IOP and the use of medications from baseline. Safety was determined by the rate of adverse events and secondary surgical interventions. The time points assessed were baseline and postoperative day 1, week 1, and months 1, 3, 6, and 12. A subgroup analysis was performed on eyes with medicated preoperative IOP values of ≥25 mmHg.
Results: The reductions in IOP from 1 day to 12 months postoperatively were statistically significant compared to baseline values. The mean reduction in IOP at 12 months was 7.3±6.7 mmHg from baseline. At 12 months, 59% eyes achieved ≥20% reduction in IOP and IOP <18 mmHg with the same or fewer numbers of IOP-lowering medications compared with those at baseline. The mean number of IOP-lowering medications was reduced from 1.7±1.3 at baseline to 1.1±1.0 at 12 months. At 12 months, 67% of eyes with preoperative IOP values of ≥25 mmHg achieved ≥20% reduction in IOP and IOP <18 mmHg with the same or fewer numbers of IOP-lowering medications compared with those at baseline. The most common adverse event for all eyes was mild, transient hyphema (57 eyes). During the first year after the procedure, 20 (25%) eyes were considered failures since they required reinterventions.
Conclusion: Trabeculotomy using the TRAB360 device resulted in significant IOP reductions up to 1 year with a favorable safety profile. The device is an effective stand-alone MIGS procedure for patients with refractory POAG.

Keywords: 360 degree trabeculotomy, glaucoma, Schlemm’s canal, blebless MIGS, TRAB360

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