One Week of Levofloxacin Plus Dexamethasone Eye Drops for Cataract Surgery: An Innovative and Rational Therapeutic Strategy

Abstract

Background Cataract surgery is the most common operation performed worldwide. A fixed topical corticosteroid-antibiotic combination is usually prescribed in clinical practice for 2 or more weeks to treat post surgical inflammation and prevent infection. However, this protracted schedule may increase the incidence of corticosteroid-related adverse events and notably promote antibiotic resistance. Methods This International, multicentre, randomized, blinded-assessor, parallel-group clinical study evaluated the noninferiority of 1-week levofloxacin/dexamethasone eye drops, followed by 1-week dexamethasone alone, vs. 2-week goldstandard tobramycin/dexamethasone (one drop QID for all schedules) to prevent and treat ocular inflammation and prevent infection after uncomplicated cataract surgery. Non-inferiority was defined as the lower limit of the 95% confidence interval (CI) around a treatment difference >-10%. The study randomized 808 patients enrolled in 53 centres (Italy, Germany, Spain and Russia). The primary endpoint was the proportion of patients without anterior chamber inflammation on day 15 defined as the end of treatment. Endophthalmitis was the key secondary endpoint. This study is registered with EudraCT code: 2018-000286-36. Results After the end of treatment, 95.2% of the patients in the test arm vs. 94.9% of the control arm had no signs of inflammation in the anterior chamber (difference between proportions of patients = 0.028; 95% CI: −0.0275/0.0331). No case of endophthalmitis was reported. No statistically significant difference was evident in any of the other secondary endpoints. Both treatments were well tolerated. Conclusions Non-inferiority of the new short pharmacological strategy was proven. One week of levofloxacin/dexamethasone prevents infection, ensures complete control of inflammation in almost all patients and may contain antibiotic resistance.

Current Challenges in the Postoperative Management of Cataract Surgery

“…To address this issue, a recent international, multicentre, randomized, non-inferiority trial (EudraCT code: 2018-000286-36) in 808 patients tested the efficacy and safety of a 1-week course of topical levofloxacin plus dexamethasone eye drops after cataract surgery, followed by 1 week of dexamethasone alone. 26 The main endpoint was the absence of inflammation in the anterior chamber 15 days after surgery as compared with a 2-week course of tobramycin plus dexamethasone; both the treatment groups received one drop four times daily. Both groups showed similar features at baseline, with a mean ± standard deviation (SD) age of 71.98 ± 8.59 years and a mean ± SD visual acuity of 0.41 ± 0.25 decimal.…”

“…At the end of the treatment, 95.19% of the levofloxacin plus dexamethasone arm and 94.91% of the control arm had no inflammation in the anterior chamber (difference: 0.028; 95% confidence interval: -0.027, 0.033), demonstrating a non-inferiority of the short-course treatment with levofloxacin compared with the other regimen. 26 Short antibiotic courses have advantages over longer therapies, such as fewer side effects, less bacterial resistance and, theoretically, lower treatment costs. 23 Quick recovery after cataract surgery is expected by many patients.…”

“…In the non-inferiority trial mentioned above, corneal oedema was observed at similar rates in patients treated with the levofloxacin and dexamethasone treatment regimen compared with the tobramycin plus dexamethasone regimen (3.29% and 4.83% of patients, respectively). 26 Touching or damaging the iris increases the risk of ocular inflammation, not only in the anterior segment, but also in the retina, with macular oedema. More than 95% of the patients treated with levofloxacin and dexamethasone had no ocular inflammation 15 days after cataract surgery, demonstrating that this postoperative management may help to achieve the goal of rapid and safe recovery.…”

“…More than 95% of the patients treated with levofloxacin and dexamethasone had no ocular inflammation 15 days after cataract surgery, demonstrating that this postoperative management may help to achieve the goal of rapid and safe recovery. 26 Long-term postoperative management after cataract surgery is another topic of debate. Additional studies are awaited regarding the optimal duration and choice of NSAIDs, the use of lubricants and the timing of follow-up.…”

Post-surgical management of cataract: Light and dark in the 2020s

“…To address this topic, a clinical trial on cataract surgery has been recently conducted to verify the hypothesis that treatment with an antibiotic-corticosteroid fixed combination could last just 1 week, according to the estimated time of inflammation resolution and wound repair. 25 The trial was a multicenter, randomized, blinded-assessor, parallel group study (LEADER7). The compared treatments were: levofloxacin 5 mg/mL + dexamethasone 1 mg/mL eye drops 4 times/daily for 7 days, followed by dexamethasone eye drops for another 7 days, versus the current standard treatment (tobramycin 3 mg/mL + dexamethasone 1 mg/mL eye drops, Tobradex®, Alcon, Milan, Italy) for 14 days.…”