Performance And Safety Of Routine Cataract Surgery With Visiol

The objective of this observational study was to proactively collect further data on the performance and safety of VISIOL (2% sodium hyaluronate with 0.5% mannitol) in routine cataract surgery, where this ophthalmic viscosurgical device (OVD) is used to create and maintain a deep anterior chamber to provide a better visibility to the surgeon and to protect the intraocular tissues during surgical manoeuvres. Since VISIOL is an aid to surgery, collected data would reflect the overall performance and safety of the surgery with VISIOL and might allow expanding the knowledge on the device and substantiating product claims stated by the manufacturer.

This study was conducted in the Thai hospitals setting. One centre is a public university hospital and the remaining two are public hospitals affiliated to medical schools in ophthalmology. The investigators implicated in this study were all trained ophthalmologists and/or ophthalmologic surgeons, who routinely perform cataract surgery via phacoemulsification and intraocular lens (IOL) implantation with the aid of VISIOL, a hyaluronic acid-based OVD containing mannitol as free radical scavenger.

This was a prospective, observational, case-only post-market clinical follow-up study. Patients who were planned to undergo a cataract surgery with the aid of VISIOL were recruited. Candidates were screened for inclusion within 60 days before the intervention. Surgery was performed based on each surgeon’s conventional practice to reflect real-life use of VISIOL. Intra-surgery information was collected. Investigator’s performance of VISIOL was also rated. Each patient was followed up for 3 months. At each visit, outcomes of the surgical procedure were assessed using non-contact specular microscopy and slit lamp biomicroscopy. Best corrected visual acuity (BCVA) and intraocular pressure (IOP) were also measured.

100 patients were included in the study and underwent cataract surgery with VISIOL. The mean age was 67.4±8.4 years. The mean postoperative BCVA improved from logMAR 0.68±0.69 pre-surgery to 0.088±0.27 and 0.084±0.24 after 1 and 3 months, respectively (p<.0001). Mean endothelial cell loss was -6.3% at 3 months (p<0.0001). Grading of corneal stromal oedema did not significantly change after the intervention (p=0.0442). Anterior chamber inflammation was progressively decreased to grade 0-1 in all cases at 1 month. Average IOP did not increase significantly after surgery (+0.4±4.7 mmHg at one day post-surgery, p=0.3378). Three IOP peaks ≥30 mmHg were detected. All of them resolved spontaneously within max. 1.5 hour.

VISIOL is a viscoadaptive OVD offering the advantages of both cohesive and dispersive substances. In this study, 78% of investigators rated VISIOL as very effective for the ease of VISIOL injection, 79% and 99% for the maintenance of the anterior chamber depth during capsurorhexis and phacoemulsification, 98% for the ease of capsulorhexis, 99% for the ease removal, and 100% for the clarity of the substance and ease of IOL implantation. All the investigators found that VISIOL was very effective during the surgery. Three months after the intervention, investigators considered that 98% of the interventions provided great improvement. VISIOL was shown to be safe when used in routine cataract surgery.