6-MONTH REAL WORLD OUTCOMES OF THE OMNI® SURGICAL SYSTEM AT A REGIONAL NHS OPHTHALMIC CENTRE IN THE UK

To determine real world outcomes of the OMNI® Surgical System

Real-world setting within a standard UK regional NHS ophthalmic centre.

This retrospective review examined all OMNI® surgeries performed from October 5, 2022, to August 23, 2023. Baseline data was compared with 6-month outcomes including intraocular pressure (IOP), number of medications, complications, and further glaucoma surgery. Statistical analysis involved paired and independent samples t-tests.

94 eyes of 86 patients were identified. The mean baseline mean deviation was 8.9 (±7.2) dB on Humphrey 24-2 visual fields. Mean visual acuity was 0.15 (LogMAR) pre-operative and post-operatively (p = 0.106). Average viscocanaloplasty and trabeculotomy was 325 and 153 degrees respectively. 42 (45%) eyes had 360 degrees viscocanaloplasty and 180 degrees trabeculotomy.

6-month data was available for 42 eyes. 20 (48%) eyes were standalone OMNI and 22 (53%) eyes were combined with cataract surgery. 33 (79%) had no prior glaucoma surgery, 6 (14%) had a history of trabeculectomy, 1 (2%) eye had iStent and 2 (5%) had multiple prior procedures. Most eyes (25 or 60%) had primary open angle glaucoma (POAG), 9 (21%) primary angle closure glaucoma (PACG), 6 (14%) normal tension glaucoma and 2 (5%) were pseudo-exfoliation glaucoma.

Baseline mean IOP was 20.76(±7.70) mmHg and 6-month 15.94(±5.72) mmHg, corresponding to a mean IOP lowering of 4.82 mmHg or 23.2% (p < 0.001). Baseline medications were 2.43(±1.06) and 6-month was 1.00(±1.15) equalling 1.43 less medications (p < 0.001).

Subgroup analysis showed that those with baseline IOP < 18mmHg had a mean increase in IOP at 6-months, however this did not reach statistical significance (p = 0.085). Mean reduction of medication was higher at 2.0 medications (p < 0.001). Those with a baseline IOP ≥ 18mmHg, had significantly better reduction in IOP than their counterparts (33.9%) (p < 0.001) and a reduction in topical medications of 1.15 agents (p = 0.032).

There was no statistically significant difference in mean IOP reduction or reduction in number of topical medications between eyes with standalone surgery and those with surgery combined with cataract surgery, those with a history of trabeculectomy and those with no prior glaucoma surgery, or between eyes with POAG and PACG.

Complications included hyphaema 4 (10%), early raised (>21mmHg) IOP 11 (26%), late raised IOP (>30 days post op) 4 (10%) and iridodialysis 1 (2%). Further surgeries included repeat OMNI 3 (7%) and Preserflo 1 (1%).

In this real-world study, including patients with moderate to advanced glaucoma, OMNI® surgery resulted in a statistically significant reduction in IOP and in topical glaucoma treatment at 6 months. No significant differences were observed for glaucoma type, combination surgery, or prior trabeculectomy.  Patients with lower baseline IOP experienced medication reduction but no significant change in IOP.