Efficacy and Tolerability of a Combined MoxifloxacinDexamethasone Formulation for Topical Prophylaxis in Phacoemulsification : An Open-Label Single-Arm Clinical Trial

الملخص EN

Background.

The use of a fixed-combination antibiotic corticosteroid for infection prophylaxis in Asian patients undergoing phacoemulsification has not been reported.

Methods.

A 15-day, open-label, single-arm trial of 64 patients for phacoemulsification with intraocular lens (IOL) implantation is described.

Patients applied moxifloxacin 0.5%/dexamethasone 0.1% (Vigadexa) eye drops four times daily before and until 15 days after surgery.

Anterior chamber (AC) reaction, visual acuity, ocular pain and signs, and intraocular pressure (IOP) were assessed at baseline and on postoperative days 1, 3, 8, and 15.

Results.

At day 15, 55 (91.7%) patients scored 0 (<5 cells) in AC reaction.

No surgery-related infection occurred.

Mean best-corrected visual acuity improved 0.5 logMAR from baseline to 0.0 logMAR (P<.0001).

Mean IOP remained at 12-13 mm Hg over the 15-day treatment.

Only 2 patients (3.1%) reported minimum ocular pain.

Two (3.1%) patients were shifted to prednisolone acetate for severe inflammation.

At the end of the study period, 8.3% were given fluorometholone for 1 week for AC reaction grade >0.

No drug-related adverse event was reported.

Conclusion.

Following phacoemulsification and IOL implantation, the topical combination moxifloxacin 0.5%/dexamethasone 0.1% was effective in preventing infection and controlling inflammation and was well tolerated.