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  • Title: A Randomized Controlled Trial Comparing STREAMLINE Canaloplasty to Trabecular Micro-Bypass Stent Implantation in Primary Open-Angle Glaucoma.
    Author: Goldberg DF, Orlich C, Flowers BE, Singh IP, Tyson S, Seibold LK, ElMallah MK, Ison EM, Harbin M, Reynolds H, Kahook MY.
    Journal: Clin Ophthalmol; 2024; 18():2917-2928. PubMed ID: 39429442.
    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.
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