PURPOSE: To evaluate the results of the prophylactic use of mitomycin-C to inhibit haze formation after excimer laser photorefractive keratectomy (PRK) for medium and high myopia in eyes that were not good candidates for laser in situ keratomileusis (LASIK). SETTING: Carones Ophthalmology Center, Milan, Italy. METHODS: This prospective randomized masked study comprised 60 consecutive eyes (60 patients). The inclusion criteria were a spherical equivalent correction between -6.00 and -10.00 diopters (D) and inadequate corneal thickness to allow a LASIK procedure with a residual stromal thickness of more than 250 microm. The eyes were divided into 2 groups according to the randomization protocol. After PRK, the study group eyes were treated with a single intraoperative dose of mitomycin-C (0.2 mg/mL), applied topically with a soaked microsponge placed over the ablated area and maintained for 2 minutes. The control eyes did not receive this treatment. Refraction, uncorrected visual acuity (UCVA), best corrected visual acuity (BCVA), and slitlamp evidence of corneal opacity (haze) or other visible complications were evaluated. RESULTS: No toxic or side effects were encountered postoperatively. No study group eye had a haze rate higher than 1 during the 6-month follow-up; 19 eyes (63%) in the control group did (P =.01). At 6 months, the between-group difference in the refractive outcome was statistically significant (P =.05), with 26 study group eyes (87%) and 14 control eyes (47%) within +/-0.50 D of the attempted correction. No study group eye had a BCVA loss during the follow-up; 7 control eyes had lost 1 to 3 lines at 6 months (P =.0006). CONCLUSIONS: The prophylactic use of a diluted mitomycin-C 0.02% solution applied intraoperatively in a single dose after PRK produced lower haze rates, better UCVA and BCVA results, and more accurate refractive outcomes than those achieved in the control group.
RCT Entities:
PURPOSE: To evaluate the results of the prophylactic use of mitomycin-C to inhibit haze formation after excimer laser photorefractive keratectomy (PRK) for medium and high myopia in eyes that were not good candidates for laser in situ keratomileusis (LASIK). SETTING: Carones Ophthalmology Center, Milan, Italy. METHODS: This prospective randomized masked study comprised 60 consecutive eyes (60 patients). The inclusion criteria were a spherical equivalent correction between -6.00 and -10.00 diopters (D) and inadequate corneal thickness to allow a LASIK procedure with a residual stromal thickness of more than 250 microm. The eyes were divided into 2 groups according to the randomization protocol. After PRK, the study group eyes were treated with a single intraoperative dose of mitomycin-C (0.2 mg/mL), applied topically with a soaked microsponge placed over the ablated area and maintained for 2 minutes. The control eyes did not receive this treatment. Refraction, uncorrected visual acuity (UCVA), best corrected visual acuity (BCVA), and slitlamp evidence of corneal opacity (haze) or other visible complications were evaluated. RESULTS: No toxic or side effects were encountered postoperatively. No study group eye had a haze rate higher than 1 during the 6-month follow-up; 19 eyes (63%) in the control group did (P =.01). At 6 months, the between-group difference in the refractive outcome was statistically significant (P =.05), with 26 study group eyes (87%) and 14 control eyes (47%) within +/-0.50 D of the attempted correction. No study group eye had a BCVA loss during the follow-up; 7 control eyes had lost 1 to 3 lines at 6 months (P =.0006). CONCLUSIONS: The prophylactic use of a diluted mitomycin-C 0.02% solution applied intraoperatively in a single dose after PRK produced lower haze rates, better UCVA and BCVA results, and more accurate refractive outcomes than those achieved in the control group.
Authors: Danny S Roh; Amanda L Cook; Steven S Rhee; Amar Joshi; Regis Kowalski; Deepinder K Dhaliwal; James L Funderburgh Journal: Invest Ophthalmol Vis Sci Date: 2008-07-24 Impact factor: 4.799