A Randomized Controlled Trial Comparing STREAMLINE Canaloplasty to Trabecular Micro-Bypass Stent Implantation in Primary Open-Angle Glaucoma

Damien F Goldberg; Claudio Orlich; Brian E Flowers; Inder P Singh; Sydney Tyson; Leonard K Seibold; Mohammed K ElMallah; Elysia M Ison; Med Harbin; Heather Reynolds; Malik Y Kahook

doi:10.2147/OPTH.S481945

A Randomized Controlled Trial Comparing STREAMLINE Canaloplasty to Trabecular Micro-Bypass Stent Implantation in Primary Open-Angle Glaucoma

Clin Ophthalmol. 2024 Oct 16:18:2917-2928. doi: 10.2147/OPTH.S481945. eCollection 2024.

Authors

Affiliations

¹ Wolstan & Goldberg Eye Associates, Torrance, CA, USA.
² Clinica 20/20, San Jose, Costa Rica.
³ Ophthalmology Associates, Fort Worth, TX, USA.
⁴ The Eye Centers of Racine & Kenosha, Racine, WI, USA.
⁵ Eye Associates & SurgiCenter of Vineland, Vineland, NJ, USA.
⁶ Department of Ophthalmology, University of Colorado Eye Center, Aurora, Colorado, USA.
⁷ Ocala Eye, Ocala, FL, USA.
⁸ New World Medical, Rancho Cucamonga, CA, USA.
⁹ Department of Ophthalmology, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.

Abstract

Purpose: To report interim results of the VENICE study, a multi-center, randomized, controlled trial (RCT) comparing STREAMLINE Surgical System (STREAMLINE) canaloplasty with iStent inject W (iStent W) implantation in patients with mild-to-moderate primary open-angle glaucoma (POAG) undergoing phacoemulsification.

Patients and methods: Safety and efficacy analyses involving the first 72 randomized eyes are included in this report. Following pre- (Screening) and post-medication washout (Eligibility) visits, one eye per subject was randomized 1:1 to STREAMLINE or iStent W after undergoing uncomplicated phacoemulsification. Subjects were evaluated postoperatively at Day 1, Week 1, Month 1, 3, and 6. Intraocular pressure (IOP) measurements, number of IOP-lowering medications, and adverse events (AEs) were assessed at each follow-up visit.

Results: Seventy-two eyes were randomized; 35 underwent STREAMLINE canaloplasty and 37 were implanted with the iStent W. Seventy eyes completed their 6-month follow-up. Both the mean morning post-washout Baseline IOP between STREAMLINE 24.86±3.05 mmHg and iStent W 25.16±3.41 mmHg and the mean IOP at 6 months between STREAMLINE eyes 16.52±3.63 mmHg and iStent W eyes 16.08±3.19 mmHg were not statistically significantly different (p=0.691 and 0.596, respectively). At 6 months, more eyes were on zero glaucoma medications in the STREAMLINE group (81.8%) compared to the iStent W group (78.4%). In medication-free eyes, the mean IOP was reduced from 24.80±2.79 mmHg to 16.00±3.40 mmHg and 24.60±3.18 mmHg to 15.80±2.21 mmHg in the STREAMLINE and iStent W groups, respectively (p=0.752). Both groups showed reduction in IOP-lowering medications at every visit, compared to pre-washout (Screening), with STREAMLINE resulting in numerically fewer medications 0.20±0.48 compared to iStent W 0.40±0.79 at 6 months (P=0.384). AEs were mild and self-limited.

Conclusion: To our knowledge, the VENICE trial is the first RCT involving canaloplasty. These interim findings demonstrated comparable IOP and medication reduction between STREAMLINE canaloplasty and iStent W implantation, when combined with phacoemulsification.

Keywords: MIGS; POAG; STREAMLINE; canaloplasty; iStent inject W; microinvasive glaucoma surgery; primary open-angle glaucoma.

Publication types

Case Reports
Clinical Trial

Grants and funding

This clinical study was sponsored by New World Medical (Rancho Cucamonga, CA).