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

Area of Science:

• Ophthalmology
• Surgical Devices

Background:

• Cataract surgery necessitates ophthalmic viscosurgical devices (OVDs) for anterior chamber stabilization and corneal endothelium protection during phacoemulsification.
• VISIOL, a viscoadaptive OVD containing sodium hyaluronate and mannitol, aims to enhance surgical safety and minimize endothelial trauma.
• Limited contemporary real-world data exists for VISIOL's performance.

Purpose of the Study:

• To prospectively evaluate the performance and safety of VISIOL in routine cataract surgery.
• To assess VISIOL's efficacy in maintaining anterior chamber stability and protecting the corneal endothelium.
• To gather real-world data on VISIOL in accordance with ISO 15798 standards.

Main Methods:

• A prospective, post-market clinical follow-up study involving adult patients undergoing phacoemulsification at Thai tertiary hospitals.
• VISIOL was used as a surgical aid, with intraocular pressure (IOP) and surgeon evaluations recorded during surgery.
• Corneal integrity, anterior chamber inflammation, IOP, and best-corrected visual acuity (BCVA) were assessed preoperatively and up to 90 days postoperatively.

Main Results:

• Mean BCVA significantly improved from logMAR 0.68 to 0.084 (p < 0.0001) by 3 months post-surgery.
• Endothelial cell density showed a mean decrease of 6.3% at 3 months (p < 0.0001).
• Surgeons reported high effectiveness for anterior chamber maintenance (79-99%) and ease of use (98-99%).

Conclusions:

• VISIOL demonstrated excellent safety and favorable surgical outcomes in patients with severe cataracts, including those with glaucoma.
• The device was associated with minimal complications and effective management of the anterior chamber during phacoemulsification.
• VISIOL supports safer surgical maneuvers and contributes to positive visual acuity outcomes post-cataract surgery.