Effect of Short Versus Long-Term Steroid on Corneal Haze After Photorefractive Keratectomy: A Randomized, Double-Masked Clinical Trial.

PURPOSE

To compare the effect of duration of fluorometholone 0.1% treatment on corneal haze after photorefractive keratectomy (PRK) with mitomycin C (MMC) 0.02%.

DESIGN

Prospective, randomized, double-blind, clinical trial.

METHODS

Single-center clinical trial of 252 myopic PRK candidates (252 eyes) aged 21 to 40 years with a mean spherical equivalent (SE) of ≤ 6 diopters (D). Participants were randomized to receive one of the three corticosteroid regimens after PRK: Group A = 1 month followed by 2-month placebo; Group B = 2 months followed by 1-month placebo; and Group C = 3 months. The main outcome measures were corneal haze incidence, subjective SE, uncorrected distance visual acuity (UDVA), and corneal densitometry.

RESULTS

The corneal haze incidence (Grade ≥ 1) at 12 months was 1.35% (1/74 eyes) in Group A and 0% in the other two groups. The mean anterior corneal densitometry (grayscale unit) was 21.19 ± 2.07, 21.09 ± 2.19, and 21.31 ± 2.21 in Groups A, B and C, respectively. The mean SE was 0 ± 0.09, 0 ± 0.11, and 0 ± 0.10, and UDVA (decimal) was 1 ± 0, 1 ± 0.01, and 1 ± 0 in Groups A, B and C, respectively. During 1-year follow-up, no statistically significant difference was observed in mean SE (P = .158), UDVA (P = .343), and anterior corneal densitometry (P = .109) at any stage between the study groups.

CONCLUSIONS

Long-term topical corticosteroids are unnecessary following PRK with MMC for moderate myopia.