Clinical Ophthalmology (Oct 2024)

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

  • Goldberg DF,
  • Orlich C,
  • Flowers BE,
  • Singh IP,
  • Tyson S,
  • Seibold LK,
  • ElMallah MK,
  • Ison EM,
  • Harbin M,
  • Reynolds H,
  • Kahook MY

Journal volume & issue
Vol. Volume 18
pp. 2917 – 2928

Abstract

Read online

Damien F Goldberg,1 Claudio Orlich,2 Brian E Flowers,3 Inder P Singh,4 Sydney Tyson,5 Leonard K Seibold,6 Mohammed K ElMallah,7 Elysia M Ison,8 Med Harbin,8 Heather Reynolds,8 Malik Y Kahook9 1Wolstan & Goldberg Eye Associates, Torrance, CA, USA; 2Clinica 20/20, San Jose, Costa Rica; 3Ophthalmology Associates, Fort Worth, TX, USA; 4The Eye Centers of Racine & Kenosha, Racine, WI, USA; 5Eye Associates & SurgiCenter of Vineland, Vineland, NJ, USA; 6Department of Ophthalmology, University of Colorado Eye Center, Aurora, Colorado, USA; 7Ocala Eye, Ocala, FL, USA; 8New World Medical, Rancho Cucamonga, CA, USA; 9Department of Ophthalmology, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USACorrespondence: Malik Y Kahook, Department of Ophthalmology, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA, Tel +1 720 848 2501, Email [email protected]: 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: primary open-angle glaucoma, POAG, STREAMLINE, iStent inject W, canaloplasty, microinvasive glaucoma surgery, MIGS

Keywords