Gatifloxacin/Prednisolone Fixed-Dose Combination for Topical Prophylaxis and Inflammation Control after Phacoemulsification

3 Dec, 20

Introduction

Considering the high risk of endophthalmitis following cataract surgery, antibiotic and anti-inflammatory eye drops form an essentially integral part of post-operative management. Fixed-dose combinations of the above medications have been formulated to cut down the number of required applications and to minimise the potential toxic effect due to preservatives.

Aim

To compare the efficacy and tolerability of a fixed combination of 0.3% gatifloxacin and 1% prednisolone with the individual components used separately for infection prophylaxis and inflammation control following cataract surgery with intraocular lens (IOL) implantation.

Patient Profile

Patients with cataract who underwent phacoemulsification and IOL implantation in one eye (n=108).

Methods

Study Design

A prospective, randomized, double-blind, parallel-group study

Treatment Strategy

Patients were randomized to receive the following treatment four times a day for 15 days

Patients were assessed at baseline and post-operatively on days 1, 7, 15, and 20
Assessments included:
- Best-corrected visual acuity (BCVA)
- Signs of active ocular inflammation
- Conjunctival hyperemia and central and incisional corneal edema
- Subjective ranking of pain on a 5-point scale (0-no pain, 5-severe pain)

Results

All objective (BCVA, sign of active ocular inflammation, central and incisional corneal edema, the number of cells per high-power field in the anterior chamber, and intraocular pressure) and subjective (eye pain, photophobia, burning sensation, itching, and foreign body sensation) criteria of efficacy did not differ in both the study groups.
Visual acuity improved from a mean of 0.3 logMAR on postoperative day 1 to 0.1 logMAR on postoperative day 20 in both groups.
Regarding anterior chamber cell counting, both groups presented an average of 21 to 50 cells (score 3) on post-operative day 1, and a reduction to less than five cells (score 0) was observed in both groups at the end of the follow-up period (Figure 3).
Flare was similar for both groups during the study, gradually decreasing over time.
Patients in Group II exhibited slightly higher intraocular pressure (p<0.05).

Conclusion

Treatment with the fixed-dose combination of gatifloxacin/prednisolone eye drops was equally effective as the non-fixed combination in preventing infection and controlling inflammation following phacoemulsification and IOL implantation.
Use of fixed-dose combination provides better treatment compliance, and increases the likelihood of receiving the proper dosage.

Clinics. 2013;68(6):834-839.