OBJECTIVE: To evaluate the benefit and safety of topical corticosteroids after laser in situ keratomileusis (LASIK). DESIGN: Prospective, randomized, double-masked clinical trial. PARTICIPANTS: A consecutive series of 1747 eyes in 897 patients desiring surgical correction of myopia from plano to -16 diopters (D) with up to 6 D of astigmatism. INTERVENTION: Patients were randomly assigned to topical corticosteroids or artificial tears. MAIN OUTCOME MEASURES: The primary outcome measure was stability of refraction. Secondary outcome measures were differences in best-corrected visual acuity, decrease in spherical refractive myopia, improvement in uncorrected visual acuity, predictability of achieved corrections versus planned corrections, evaluation of postoperative haze, preservation of best-corrected visual acuity, intraocular pressure, and incidence of complications and adverse events. RESULTS: No difference was found between the groups for refractive accuracy, best-corrected or uncorrected visual acuity, or safety. Topical corticosteroids were associated with a prolonged period of refractive regression in moderate to high myopes (-7.25 to -16.00 D) (P = 0.01). Increased haze was noted at the 1 week examination for eyes not receiving topical steroids (P = 0.008); however, in most cases this was clinically insignificant. Thirty-six eyes (2.1%) required supplemental topical corticosteroids unrelated to reoperation. Two eyes received these on the first postoperative day and 15 at the 1-week examination. CONCLUSIONS:Topical corticosteroids did not seem to play any beneficial role in routine postoperative treatment after LASIK, and they were associated with decreased stability of refraction in more highly myopic eyes. Eyes that require additional topical corticosteroids are easily identified at either the initial postoperative examinations or during the course of routine postoperative care.
RCT Entities:
OBJECTIVE: To evaluate the benefit and safety of topical corticosteroids after laser in situ keratomileusis (LASIK). DESIGN: Prospective, randomized, double-masked clinical trial. PARTICIPANTS: A consecutive series of 1747 eyes in 897 patients desiring surgical correction of myopia from plano to -16 diopters (D) with up to 6 D of astigmatism. INTERVENTION: Patients were randomly assigned to topical corticosteroids or artificial tears. MAIN OUTCOME MEASURES: The primary outcome measure was stability of refraction. Secondary outcome measures were differences in best-corrected visual acuity, decrease in spherical refractive myopia, improvement in uncorrected visual acuity, predictability of achieved corrections versus planned corrections, evaluation of postoperative haze, preservation of best-corrected visual acuity, intraocular pressure, and incidence of complications and adverse events. RESULTS: No difference was found between the groups for refractive accuracy, best-corrected or uncorrected visual acuity, or safety. Topical corticosteroids were associated with a prolonged period of refractive regression in moderate to high myopes (-7.25 to -16.00 D) (P = 0.01). Increased haze was noted at the 1 week examination for eyes not receiving topical steroids (P = 0.008); however, in most cases this was clinically insignificant. Thirty-six eyes (2.1%) required supplemental topical corticosteroids unrelated to reoperation. Two eyes received these on the first postoperative day and 15 at the 1-week examination. CONCLUSIONS: Topical corticosteroids did not seem to play any beneficial role in routine postoperative treatment after LASIK, and they were associated with decreased stability of refraction in more highly myopic eyes. Eyes that require additional topical corticosteroids are easily identified at either the initial postoperative examinations or during the course of routine postoperative care.