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Clinical Trial
Journal Article
Randomized Controlled Trial
The effects of topical steroids on refractive outcome and corneal haze, thickness, and curvature after photorefractive keratectomy with a 6.0-mm ablation diameter.
Ophthalmic Surgery and Lasers 1998 August
BACKGROUND AND OBJECTIVE: To study the effect of topical prednisolone acetate after photorefractive keratectomy (PRK) using a 6.0-mm ablation diameter on the refractive and visual outcomes, corneal haze, corneal thickness, and corneal curvature in a prospective, double-masked, randomized manner.
PATIENTS AND METHODS: Seventy-two eyes of 36 patients who had excimer laser PRK for correction of myopia ranging from -3.00 to -6.00 D (-4.11 +/- 0.84 D in eyes treated with steroids and -4.38 +/- 0.79 D in eyes treated with placebo; mean +/- SD) were enrolled. PRK procedures were performed using a 193-nm argon-fluoride excimer laser with 180-ml/cm2 fluence, a 10-Hz repetition rate, and a 6.0-mm ablation diameter. One eye of each patient was treated with the steroid (prednisolone acetate) and the other eye with placebo. Patients were observed for at least 12 months after PRK.
RESULTS: There was no statistically significant difference between the steroid and the placebo groups with regard to refraction measurements that were taken postoperatively at 3 months (P = .39) and 12 months (P = .51). The corneas showed an increase in thickness after PRK in both groups, but the difference was not statistically significant at 12 months postoperatively (P = .45). The corneal haze score was not statistically different at any stage between groups (P = .30 at 3 months, P = .84 at 12 months). Keratometric data derived from corneal topography did not show any statistically significant difference (P = .85 at 3 months, P = .96 at 12 months). The rate of uncorrected visual acuity of 20/40 or more was 79.4% (27 eyes) in the steroid group and 70.5% (24 eyes) in the placebo group (P = .40). The rate of loss of 2 or more lines in best spectacle-corrected visual acuity was 5.85% (2 eyes) in the steroid group and 8.8% (3 eyes) in the placebo group (P = 1.0).
CONCLUSION: Topical prednisolone acetate use for 3 months after PRK with a 6.0-mm ablation diameter has no effect on refractive and visual outcome, corneal haze, corneal thickness, and corneal curvature.
PATIENTS AND METHODS: Seventy-two eyes of 36 patients who had excimer laser PRK for correction of myopia ranging from -3.00 to -6.00 D (-4.11 +/- 0.84 D in eyes treated with steroids and -4.38 +/- 0.79 D in eyes treated with placebo; mean +/- SD) were enrolled. PRK procedures were performed using a 193-nm argon-fluoride excimer laser with 180-ml/cm2 fluence, a 10-Hz repetition rate, and a 6.0-mm ablation diameter. One eye of each patient was treated with the steroid (prednisolone acetate) and the other eye with placebo. Patients were observed for at least 12 months after PRK.
RESULTS: There was no statistically significant difference between the steroid and the placebo groups with regard to refraction measurements that were taken postoperatively at 3 months (P = .39) and 12 months (P = .51). The corneas showed an increase in thickness after PRK in both groups, but the difference was not statistically significant at 12 months postoperatively (P = .45). The corneal haze score was not statistically different at any stage between groups (P = .30 at 3 months, P = .84 at 12 months). Keratometric data derived from corneal topography did not show any statistically significant difference (P = .85 at 3 months, P = .96 at 12 months). The rate of uncorrected visual acuity of 20/40 or more was 79.4% (27 eyes) in the steroid group and 70.5% (24 eyes) in the placebo group (P = .40). The rate of loss of 2 or more lines in best spectacle-corrected visual acuity was 5.85% (2 eyes) in the steroid group and 8.8% (3 eyes) in the placebo group (P = 1.0).
CONCLUSION: Topical prednisolone acetate use for 3 months after PRK with a 6.0-mm ablation diameter has no effect on refractive and visual outcome, corneal haze, corneal thickness, and corneal curvature.
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