Prospective Study of Canaloplasty and Trabeculotomy Performed by Trainees

Abstract

Purpose

To evaluate outcomes of new adopters of the OMNI^® Surgical System (Sight Sciences, Inc.) by prospectively evaluating intermediate-term outcomes of patients operated by trainees.

Patients and Methods

This was a prospective study of surgeries performed by trainees on patients with open angle glaucoma undergoing simultaneous cataract surgery and ab interno canaloplasty and trabeculotomy using the OMNI Surgical System. Pre-operative intraocular pressure (IOP) and number of glaucoma medications were recorded. Only patients with a minimum of 6-month follow up were included. Baseline IOP was used to separate subjects into two groups: Group 1 (IOP ≥18 mmHg) and Group 2 (IOP <18 mmHg). Mean decrease in IOP and medications was calculated and compared with paired t-tests for the overall sample as well as the subgroups. Success was defined as those with a ≥20% reduction from pre-operative IOP or with an IOP ≤18 mmHg and ≥6 mmHg and on the same or fewer number of medications while not requiring additional surgery. Adverse events were also recorded.

Results

Forty-two eyes of 31 patients were included. Mean pre-operative IOP was 17.2 ± 4.8 mmHg and mean number of medications was 2.4 ± 1.2. The primary endpoint was reached in 83.3% of patients at 12 months. IOP was reduced by 22.3% to 13.4 ± 2.4 (p<0.001). Mean number of medications decreased to 1.7 ± 1.6 (p<0.001). Group 1 mean IOP decreased 35.4% from 22.2 ± 4.6 mmHg to 14.3 ± 2.8 mmHg (p<0.001). Group 2 mean number of medications decreased from 2.3 ± 1.1 to 1.6 ± 1.5 (p<0.001).

Conclusion

When operated on by the novice MIGS surgeon, the OMNI device provides effective IOP and glaucoma medication reduction with minimal adverse events. Efficacy and safety of the device in the hands of trainees was comparable to experienced glaucoma surgeons suggesting its ease of adoption.

Keywords:

• OMNI
• canaloplasty
• trabeculotomy
• goniotomy
• MIGs
• minimally invasive glaucoma surgeries

Data Sharing Statement

The authors do not intend to share the data of the participants. Requests should be directed to the corresponding author.

Disclosure

Research reported in this publication was supported by a grant from Sight Sciences Inc, who is the manufacturer of the OMNI^® Surgical System, and an unrestricted grant from Research to Prevent Blindness to the Gavin Herbert Eye Institute at the University of California, Irvine. The authors report no other conflicts of interest.