- Research Article
- 10.1007/s40123-026-01345-w
Real-World Performance and Safety of VISIOL in Modern Routine Cataract Surgery.
- Apr 01, 2026
- Ophthalmology and therapy
- Kulawan Rojananuangnit + 5 more +5
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. 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 90days postoperatively. The study included 100 patients (mean age 67.4 ± 8.4years) 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 3months, respectively (p < 0.0001). Mean endothelial cell density change was -6.3% at 3months (p < 0.0001). Anterior chamber inflammation progressively decreased to grade 0-1 in all cases at 1month. IOP changes were nonsignificant (+0.4 ± 4.7mmHg on day 1, p = 0.3378), with the occurrence of four transient IOP peaks ≥ 30mmHg; all resolved within ≤ 1.5h 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%). In patients with severe cataracts, including those with glaucoma, VISIOL demonstrated excellent safety, minimal complications, and favourable surgical outcomes. The study was registered at ClinicalTrials.gov (registration number NCT04866706).
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