Abstract
Purpose :
This study evaluated the ability and safety of an ophthalmic solution containing Poloxamer 407 and Polyquaternium 133 (Visuprime®) in reducing conjunctival bacterial load in patients receiving cataract surgery, as an add-on treatment to standard therapy, to prevent endophthalmitis.
Methods :
This multicenter, post-market, open-label, randomized, placebo-controlled prospective study was approved by the “Lazio 2” Ethics Committee on 30.04.2021. (Protocol numbers: 0088960, 0088993).
The study consisted of 3 visits: V1 (day -3 from surgery), V2 (day 0, surgery), and V3 (day +7 from surgery).
Patients (n=74) enrolled at V1 were randomized with a 1:1 ratio to 2 groups:
patients receiving Visuprime® (GROUP A; n=37) or patients receiving placebo (Visuprime®’s vehicle; GROUP B (n=37)) two times daily from V1 to V3.
All the patients were also given standard postoperative treatment (dexamethasone unit dose eyedrop + levofloxacin eyedrop four times daily) from V2 to V3.
At all-time points, patients underwent ophthalmological examination, eye swabs, Oxford Scale and conjunctival hyperemia grading. The overall experience with Visuprime® and burning were evaluated using Likert and VAS scales respectively.
Zero-inflated negative binomial models and paired T-test were used when appropriate. A p≤0,05 was considered significant.
Results :
Intergroup analysis showed that bacterial load was significantly reduced in Visuprime® comparing V2 vs V1 (p= 0,002) and V3 vs V1 (p=0,0007). No statistically significant differences were found in the controls (p>0,05). To compare Groups, due to the presence of a large proportion of zeros and a strong right asymmetry (Skewness equal 9.6), zero-inflated negative binomial models were estimated: V2 Odds Ratio 0,44 (0,20; 0,98) p=0,044, and V3 Odds Ratio 0,72 (0,12; 4,21) p=0,71 in Visuprime® Group.
Hyperemia and Oxford Score were evaluated at V1, V2, V3 and no significant differences were found between treatment groups (p>0.05).
Comfort and burning showed no significant differences between groups (p>0.05).
Conclusions :
Overall, Visuprime® resulted well tolerated and reduced, at all time points, the bacterial load in the treated group. Moreover, the day of the surgery, the treated group had a significantly reduced bacterial load compared to the controls. Thus, suggesting the possible usefulness of Visuprime® as add-on therapy in cataract surgery.
This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.