PURPOSE: To analyze the long-term safety profile, visual and refractive results, and incidence of complications between sub-Bowman keratomileusis with 90- and 100-μm flaps. DESIGN: Prospective, randomized, comparative clinical study. METHOD:A total of 385 candidates (770 eyes) underwentbilateral, single-sitting, sub-Bowman keratomileusis, with flap creation (90 or 100 μm) on IntraLase 60-kHz (Abott Medical Optics) and ablation on Technolas 217z100 (Technolas PV) . Right and left eyes were randomized to undergo 90- or 100-μm flap procedures. Preoperative and postoperative assessment included uncorrected visual acuity (UCVA), best spectacle-corrected visual acuity (BSCVA), refraction, and topographic analysis. All cases were followed up until 12 months after surgery. After excluding cases lost to follow-up, a final analysis of 368 patients was carried out (368 eyes in each of the 2 groups). The main outcome measures were BSCVA, UCVA, complication rates, and residual spherical equivalent refractive error. RESULTS: The mean preoperative values were: spherical equivalent, -6.08 ± 2.7 diopters (D; 90-μm group) and -5.99 ± 2.8 D (100-μm group; P = .7); and logarithm of the minimal angle of resolution BSCVA, 0.01 ± 0.03 (90-μm group) and 0.01 ± 0.04 (100-μm group: P = .8). Postoperative 12-month values were: spherical equivalent, -0.02 ± 0.4 D (90-μm group) and -0.01 ± 0.4 D (100-μm group; P = .8); logarithm of the minimal angle of resolution BSCVA, -0.05 ± 0.07 (90-μm group) and -0.04 ± 0.07 (100-μm group; P = .8); and logarithm of the minimal angle of resolution UCVA, 0.012 ± 0.01 (90-μm group) and 0.017 ± 0.02 (100-μm group; P = .2). No loss of BSCVA was seen in any case. The efficacy indices were 1.039 ± 0.21 (90-μm group) and 1.014 ± 0.24 (100-μm group; P = .2); safety indices were 1.163 ± 0.21 (90-μm group) and 1.158 ± 0.22 (100-μm group; P = .6); and vision difference indices were 0.09 ± 0.14 (90-μm group) and 0.10 ± 0.15 (100-μm group; P = .1). Both groups had a low but comparable incidence of diffuse lamellar keratitis and microstriae. However, the incidence of microstriae (although visually asymptomatic) was significantly higher in ablation with spherical equivalent of -9 D or more compared with lesser ablations (6.7% vs 0.8%; P < .001). CONCLUSIONS: The 1-year follow-up of femtosecond sub-Bowman keratomileusis with 90- and 100-μm flaps suggests that both the flap options have comparable outcomes.
RCT Entities:
PURPOSE: To analyze the long-term safety profile, visual and refractive results, and incidence of complications between sub-Bowman keratomileusis with 90- and 100-μm flaps. DESIGN: Prospective, randomized, comparative clinical study. METHOD: A total of 385 candidates (770 eyes) underwent bilateral, single-sitting, sub-Bowman keratomileusis, with flap creation (90 or 100 μm) on IntraLase 60-kHz (Abott Medical Optics) and ablation on Technolas 217z100 (Technolas PV) . Right and left eyes were randomized to undergo 90- or 100-μm flap procedures. Preoperative and postoperative assessment included uncorrected visual acuity (UCVA), best spectacle-corrected visual acuity (BSCVA), refraction, and topographic analysis. All cases were followed up until 12 months after surgery. After excluding cases lost to follow-up, a final analysis of 368 patients was carried out (368 eyes in each of the 2 groups). The main outcome measures were BSCVA, UCVA, complication rates, and residual spherical equivalent refractive error. RESULTS: The mean preoperative values were: spherical equivalent, -6.08 ± 2.7 diopters (D; 90-μm group) and -5.99 ± 2.8 D (100-μm group; P = .7); and logarithm of the minimal angle of resolution BSCVA, 0.01 ± 0.03 (90-μm group) and 0.01 ± 0.04 (100-μm group: P = .8). Postoperative 12-month values were: spherical equivalent, -0.02 ± 0.4 D (90-μm group) and -0.01 ± 0.4 D (100-μm group; P = .8); logarithm of the minimal angle of resolution BSCVA, -0.05 ± 0.07 (90-μm group) and -0.04 ± 0.07 (100-μm group; P = .8); and logarithm of the minimal angle of resolution UCVA, 0.012 ± 0.01 (90-μm group) and 0.017 ± 0.02 (100-μm group; P = .2). No loss of BSCVA was seen in any case. The efficacy indices were 1.039 ± 0.21 (90-μm group) and 1.014 ± 0.24 (100-μm group; P = .2); safety indices were 1.163 ± 0.21 (90-μm group) and 1.158 ± 0.22 (100-μm group; P = .6); and vision difference indices were 0.09 ± 0.14 (90-μm group) and 0.10 ± 0.15 (100-μm group; P = .1). Both groups had a low but comparable incidence of diffuse lamellar keratitis and microstriae. However, the incidence of microstriae (although visually asymptomatic) was significantly higher in ablation with spherical equivalent of -9 D or more compared with lesser ablations (6.7% vs 0.8%; P < .001). CONCLUSIONS: The 1-year follow-up of femtosecond sub-Bowman keratomileusis with 90- and 100-μm flaps suggests that both the flap options have comparable outcomes.