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).