PURPOSE: Recently laser-in-situ-keratomileusis (LASIK) has been increasingly used to correct refractive errors. The purpose of this investigation was to evaluate the safety, efficacy, predictability, stability and complications using the scanning spot excimer LASIK technology. PATIENTS AND METHODS: The results of 100 consecutive LASIK operations carried out between 2/1998 and 2/1999 on 60 patients (mean age 37 years, range 20-55 years) have been evaluated. The Hansatome microkeratome with a superior hinge (flap diameter: 9.5 mm) and a scanning spot excimer laser (Technolas C-Lasik 217) were used in all cases. The mean spherical equivalent of the subjective manifest refraction was -6.96 +/- 2.87 diopters (D), the mean sphere was -6.47 +/- 2.71 D and the mean astigmatism was -0.98 +/- 0.94 D. In 6% of the eyes preoperative visual acuity was not better than 20/40. Examinations were performed preoperatively, after 1 and 7 days, after 1,4 and 12 months. Safety, efficacy, predictability, stability and complications were calculated using the datagraph software (version 1.11). RESULTS: All 100 eyes were examined after 1 day and 1 week, 96 after 1 month, 95 after 4 months and 92 after 1 year. Following 1 year none of the eyes lost 2 or more lines of best corrected visual acuity, 99% were within +/- 1 line and 1% gained 2 lines (safety index 1.03). In 92% of all eyes an uncorrected visual acuity of > or = 0.5 was reached, in 77% > or = 0.8 and in 51% > or = 1.0 (efficacy index 0.89). For 60 eyes (65.21%) a refractive correction of +/- 0.5 D was necessary, for 82 eyes (89.13%) +/- 1.0 D and for 91 eyes (98.91%) +/- 2.0 D. The mean spherical equivalent after 1 year was -0.15 +/- 1.31 D. Between 1 and 12 months a mean regression of -0.14 D occurred. On the request of the patients, 5 eyes were retreated during the study period for under- or over-correction. Complications due to the microkeratome did not occur. Corneal infections were not observed, a diffuse lamellar keratitis (DLK) was seen in 12 cases, but all cases healed with no loss of visual acuity. In 7 eyes a slight decentration of the ablation was observed using corneal topography, which in one case caused an increase in glare sensitivity. CONCLUSIONS: LASIK with superior hinge and scanning spot excimer photoablation is suitable for the correction of myopia (up to a maximum of -12 D) and for myopic astigmatism (up to a maximum of -5 D). The refractive results showed a high stability during the 12-month study period but there is still room for improvement of the predictability.
PURPOSE: Recently laser-in-situ-keratomileusis (LASIK) has been increasingly used to correct refractive errors. The purpose of this investigation was to evaluate the safety, efficacy, predictability, stability and complications using the scanning spot excimer LASIK technology. PATIENTS AND METHODS: The results of 100 consecutive LASIK operations carried out between 2/1998 and 2/1999 on 60 patients (mean age 37 years, range 20-55 years) have been evaluated. The Hansatome microkeratome with a superior hinge (flap diameter: 9.5 mm) and a scanning spot excimer laser (Technolas C-Lasik 217) were used in all cases. The mean spherical equivalent of the subjective manifest refraction was -6.96 +/- 2.87 diopters (D), the mean sphere was -6.47 +/- 2.71 D and the mean astigmatism was -0.98 +/- 0.94 D. In 6% of the eyes preoperative visual acuity was not better than 20/40. Examinations were performed preoperatively, after 1 and 7 days, after 1,4 and 12 months. Safety, efficacy, predictability, stability and complications were calculated using the datagraph software (version 1.11). RESULTS: All 100 eyes were examined after 1 day and 1 week, 96 after 1 month, 95 after 4 months and 92 after 1 year. Following 1 year none of the eyes lost 2 or more lines of best corrected visual acuity, 99% were within +/- 1 line and 1% gained 2 lines (safety index 1.03). In 92% of all eyes an uncorrected visual acuity of > or = 0.5 was reached, in 77% > or = 0.8 and in 51% > or = 1.0 (efficacy index 0.89). For 60 eyes (65.21%) a refractive correction of +/- 0.5 D was necessary, for 82 eyes (89.13%) +/- 1.0 D and for 91 eyes (98.91%) +/- 2.0 D. The mean spherical equivalent after 1 year was -0.15 +/- 1.31 D. Between 1 and 12 months a mean regression of -0.14 D occurred. On the request of the patients, 5 eyes were retreated during the study period for under- or over-correction. Complications due to the microkeratome did not occur. Corneal infections were not observed, a diffuse lamellar keratitis (DLK) was seen in 12 cases, but all cases healed with no loss of visual acuity. In 7 eyes a slight decentration of the ablation was observed using corneal topography, which in one case caused an increase in glare sensitivity. CONCLUSIONS: LASIK with superior hinge and scanning spot excimer photoablation is suitable for the correction of myopia (up to a maximum of -12 D) and for myopic astigmatism (up to a maximum of -5 D). The refractive results showed a high stability during the 12-month study period but there is still room for improvement of the predictability.