Medical treatment after cataract surgery: evidence for a new anti-inflammatory strategy

Session Details

Session Title: Cataract Surgery: Complications & Management

Session Date/Time: Tuesday 17/09/2019 | 14:00-16:00

Paper Time: 14:32

Venue: Free Paper Forum: Podium 1

First Author: : M.Coassin ITALY

Co Author(s): :    F. Bandello                             

Abstract Details

Purpose:

This international, multicenter, randomized, blinded-assessor, parallel-group clinical study evaluated the non-inferiority of a short term antibiotic/anti-inflammatory treatment (1-week with a combination of levofloxacin 5 mg/mL and dexamethasone 21-phosphate 1 mg/mL) followed by 1-week treatment with dexamethasone alone versus a standard 2-weeks antibiotic/anti-inflammatory treatment (tobramycin 3 mg/mL + dexamethasone 1 mg/mL) in preventing and treating ocular inflammation and in preventing infection after cataract surgery, while limiting the emergence of antibiotic resistance. All drugs were administered at the dose of 1 drop QID.

Setting:

Cataract surgery. Combined LEvofloxAcin + DExamethasone foR 7 days (LEADER 7) study enrolled 863 adult male and female patients in 53 centers in Italy, Germany, Spain and Russia. At home, patients self-administered eye drops and recorded doses for compliance assessment.

Methods:

After cataract surgery, patients underwent visits at the clinics on Day 4, Day 8 and Day 15 (end of study - EOS) to evaluate efficacy, safety and tolerability. Primary endpoint was the proportion of patients without signs of anterior chamber inflammation (sum of cells and flares = 0) after 14 days of treatment. Among secondary endpoints, proportion of patients without signs of anterior ocular chamber inflammation after 3 and 7 days of treatment, and proportion of patients without conjunctival hyperemia and with Total Symptoms Score (TOSS) = 0 after 3, 7 and 14 days of treatment were evaluated.

Results:

73.1% of patients in the test arm group achieved complete disappearance of inflammatory signs just after 3 days. This percentage increased to 85.7% at day 8 and to 95.1% at EOS. Non inferiority between test arm and control group was confirmed from a statistical point of view for all inflammatory parameters at all time points (at EOS difference between proportions of patients = 0.0028; 95% CI: -0.0275 / 0.0331).

Conclusions:

The current study evidenced for the first time that a new treatment strategy after cataract surgery, based on 1-week levofloxacin plus dexamethasone followed by 1-week dexamethasone alone, was effective in reducing cataract surgery-induced inflammation. Notably, a large majority of patient had disappearance of signs of inflammation after 1-week treatment. The results of this study could lead to a re-evaluation on the need for routine steroid therapy beyond 1 week after cataract surgery.

Financial Disclosure:

None