Real-World Outcomes of Canaloplasty and Trabeculotomy Combined with Cataract Surgery in Eyes with All Stages of Open-Angle Glaucoma

Abstract

Purpose

To evaluate the long-term safety and efficacy of sequential canaloplasty and trabeculotomy combined with cataract surgery in patients with mild, moderate, and advanced open-angle glaucoma.

Patients and Methods

Case records of 171 consecutive patients (171 eyes) who had undergone cataract surgery followed by canaloplasty (≥180°) and trabeculotomy (≥90°) for mild, moderate, or advanced open-angle glaucoma (Shaffer grade ≥3) using the OMNI Surgical System (Sight Sciences, Inc., Menlo Park, CA) were analyzed retrospectively. Efficacy endpoints included change in mean IOP and number of medications from baseline to postoperative 12- and 24-months for the overall dataset and stratified by each stage of glaucoma. Kaplan–Meier survival analysis of success (eyes that did not require secondary surgical interventions (SSI)) by postoperative 24 months was also performed.

Results

Postoperatively, there was a statistically significant reduction in IOP (baseline of 17.2 mmHg on 1.3 medicines reduced to 14.3 on 0.8 medicines (12 months) and 14.0 on 0.9 medicines (24 months), p<0.001 for both time points). Eyes with advanced glaucoma (N=63) maintained significant IOP reduction (17.8 mmHg on 1.6 medicines at baseline reduced to 13.6 mmHg on 1.3 medicines (12 months) and 13.0 on 1.5 medicines (24 months), p<0.001). Kaplan–Meier analysis showed a 93.0% survival probability for the avoidance of SSI at 2 years after surgery.

Conclusion

Canaloplasty and trabeculotomy combined with cataract surgery provided effective IOP reduction for eyes with all stages of glaucoma at postoperative 12 and 24 months, and the procedure yielded a 93% survival rate for SSI avoidance at 2 years.

Keywords:

• open-angle glaucoma
• OMNI surgical system
• combined canaloplasty and trabeculotomy
• implant-free MIGS
• mild
• moderate
• advanced glaucoma

Abbreviations

OAG, open-angle glaucoma; TM, trabecular meshwork; IOP, intraocular pressure; SC, Schlemm’s canal; MIGS, minimally invasive glaucoma surgeries; IOL, intraocular lens; CMS, Center for Medicare and Medicaid Services; SWAP, short-wavelength automated perimetry; FDT, frequency doubling technology perimetry; SSI, secondary surgical interventions; AE, adverse events; POAG, primary open-angle glaucoma.

Acknowledgments

1. The authors would like to thank Zeke Bourgeois, BS, for his contributions to this study.

2. Raman Bedi, MD critically reviewed the manuscript. IrisARC – Analytics, Research & Consulting (Chandigarh, India) provided statistical and editorial assistance in the preparation of the manuscript.

3. The abstract of this paper was presented at the 2023 ASCRS annual meeting (May 5–8, 2023 San Diego, CA) as a conference talk with interim findings. The paper’s abstract was not published.

Disclosure

AY is a consultant to SightSciences Inc. KD and QA have no conflicts of interest to disclose.

Additional information

Funding

The present study is an Investigator Initiated Trial funded by SightSciences Inc.