Real-World Performance and Safety of VISIOL in Modern Routine Cataract Surgery.

INTRODUCTION

Cataract surgery requires ophthalmic viscosurgical devices (OVDs) to stabilise the anterior chamber and protect the corneal endothelium during phacoemulsification. VISIOL, a viscoadaptive OVD containing sodium hyaluronate and mannitol, is designed to support safer surgical manoeuvres and minimise endothelial trauma. Contemporary real-world data on VISIOL remain limited. This post-market clinical follow-up prospectively evaluated VISIOL's performance and safety in routine cataract surgery in accordance with ISO 15798.

METHODS

Adult patients undergoing phacoemulsification at Thai tertiary hospitals received VISIOL as a surgical aid at any stage. Intraocular pressure (IOP) and surgeons' evaluations were recorded during surgery. Corneal integrity, anterior chamber inflammation, IOP, and best-corrected visual acuity (BCVA) were determined preoperatively and at 1, 7, 30, and 90 days postoperatively.

RESULTS

The study included 100 patients (mean age 67.4 ± 8.4 years) with severe cataracts (mean LOCS III nuclear opacity score 3.9 ± 1.4); 26% had glaucoma. Mean BCVA improved from logMAR 0.68 ± 0.69 before surgery to 0.088 ± 0.27 and 0.084 ± 0.24 after 1 and 3 months, respectively (p < 0.0001). Mean endothelial cell density change was -6.3% at 3 months (p < 0.0001). Anterior chamber inflammation progressively decreased to grade 0-1 in all cases at 1 month. IOP changes were nonsignificant (+0.4 ± 4.7 mmHg on day 1, p = 0.3378), with the occurrence of four transient IOP peaks ≥ 30 mmHg; all resolved within ≤ 1.5 h with or without treatment. Surgeons rated VISIOL as very effective for maintenance of anterior chamber depth during capsulorhexis (79%) and phacoemulsification (99%), and for the ease of capsulorhexis (98%) and removal (99%).

CONCLUSIONS

In patients with severe cataracts, including those with glaucoma, VISIOL demonstrated excellent safety, minimal complications, and favourable surgical outcomes.

TRIAL REGISTRATION: The study was registered at ClinicalTrials.gov (registration number NCT04866706).