Abstract
Abstract: :
Purpose: To compare postoperative pain and epithelial healing after LASEK surgery using topical 0.1 % Indomethacin eye drops or 0.1% Fluorometholon acetate eye drops. Methods: Prospective, randomised, double–masked clinical trial on 159 patients (age between 24 and 40 years, refractive error between –2 and –6.50D) undergoing LASEK. Patients were randomly divided into two groups. Group 1 of 80 patients (mean age 29±3 years) received 0.1% Indomethacin eye drops (Indocollirio®, Bausch&Lomb Oftal, Catania, Italy) QID, while Group 2 (79 patients, mean age 29 ±4 years) received 0.1% Fluorometholon eye drops (Flarex® , Alcon Italia, Milan, Italy) QID. Patients were evaluated 2–4 days before (T0) and 4 days after surgery (T1). Corneal fluorescein staining (score from 0 to 3 for each of the four quadrant considered), corneal aesthesiometry (Cochet–Bonnet aesthesiometer, Luneau, France) and the level of pain (according to an analogic visual scale from 0 to 10) were evaluated at T0 and T1. In addition haze was evaluated at 14+1 weeks after surgery using Fantes classification (Arch. Ophthalmol., 1990). Results: At T1 pain level was 2.02±2.01 (mean ± standard deviation) in the Indomethacin group and 6.12± 1.51 in the Fluorometholon group (p<0.0001, Mann Whitney U–test); corneal fluorescein staining was 1.40±1.26 in the Indomethacin group and 4.04±2.73 in the Fluorometholon group (p<0.0001, Mann Whitney U–test). Corneal aesthesiometry was reduced to the same extent in both groups. At T1 it was 4.45±0.60 in the Indomethacin group and 4.85±0.82 in the Fluorometholon group in comparison with T0 values of 5.92±0.20 and 5.98±0.15 respectively. Haze did not differ significantly between the two groups 14 weeks after surgery. Conclusions: Our study suggests that less pain and a faster epithelial healing process are associated with the use of 0.1% Indomethacin eye drops as compared to 0.1%Fluorometholon eye drops in patients undergoing LASEK surgery.
Keywords: refractive surgery: comparative studies • wound healing • pharmacology