High intensity focused ultrasound (HIFU) for the treatment of symptomatic breast fibroadenoma.

PURPOSE: The aim of the study was to evaluate the efficacy of high intensity focused ultrasound (HIFU) in the treatment of symptomatic breast fibroadenomas (FA) after 6 and 12 months. MATERIALS AND METHODS: Between December 2013 and November 2014, 27 patients with histologically confirmed FA received one application of HIFU under local anesthesia (NCT02011919). Follow-up visits occurred after 6 and 12 months measuring the FA volume and clinical symptoms. A volume reduction of more than 65% was defined as success. Core needle biopsy (CNB) was offered after 12 months if indistinct residuals were visible on ultrasound (US). RESULTS: A successful reduction in FA volume after 12 months was achieved in 24/27 patients (89%). At baseline 16 patients (59%) had pain, which was resolved in 63% (10/16). All patients were satisfied with the cosmetic related outcome. Twenty-four patients (89%) would repeat the procedure. After 12 months 21 patients with sonographically indistinct residuals underwent a CNB. There were no vital cells in 86%. Three cases showed vital cells of FA. Retrospectively possible reasons in these three cases were an insufficient treatment due to bad visibility and insufficient fixation of the FA during HIFU and/or a too short follow-up time. CONCLUSION: US-guided HIFU is an effective procedure and a minimally invasive alternative for the treatment of breast FA.

Preoperative breast MR Imaging in patients with primary breast cancer has the potential to decrease the rate of repeated surgeries.

PURPOSE: The impact of preoperative MRI on re-excisions and mastectomy rate is discussed controversially in the literature. Aim of this study was to evaluate the effect of preoperative breast MRI on the surgical procedure and rate of repeated surgeries. MATERIAL AND METHODS: A total of 991 consecutive patients in the years 2009 and 2010 with 1036 primary breast cancers were retrospectively analyzed. Sixty percent (599 patients with 626 cancers) received preoperative breast MRI. Planned surgical procedures before and after MRI and numbers of repeated surgeries in patients with (MR+ ) and without preoperative MRI (MR-) were compared. RESULTS: The result of preoperative MRI changed the surgical procedure in 25% (157/626) of the cases. In 81% (127/157), MRI was beneficial for the patients, as otherwise occult carcinomas were removed (n=122) or further biopsy could be prevented (n=5). Mastectomy rates did not differ between MR+ and MR- group (39% vs. 39%). On multiple regression analysis, the MR+ group had a lower chance for repeated surgery (p<0.05). CONCLUSION: Preoperative MRI could lower the chance for repeated surgery in patients with primary breast cancer. The rate of mastectomy did not differ between patients undergoing preoperative MRI and those who did not.

Repeated surgeries in invasive lobular breast cancer with preoperative MRI: Role of additional carcinoma in situ and background parenchymal enhancement.

OBJECTIVES: Analysing the influence of additional carcinoma in situ (CIS) and background parenchymal enhancement (BPE) in preoperative MRI on repeated surgeries in patients with invasive lobular carcinoma (ILC) of the breast. METHODS: Retrospective analysis of 106 patients (mean age 58.6±9.9years) with 108 ILC. Preoperative tumour size as assessed by MRI, mammography and sonography was recorded and compared to histopathology. In contrast-enhanced MRI, the degree of BPE was categorised by two readers. The influence of additionally detected CIS and BPE on the rate of repeated surgeries was analysed. RESULTS: Additional CIS was present in 45.4% of the cases (49/108). The degree of BPE was minimal or mild in 80% of the cases and moderate or marked in 20% of the cases. In 17 cases (15.7%) at least one repeated surgery was performed. In n=15 of these cases, repeated surgery was performed after BCT (n=9 re-excisions, n=6 conversions to mastectomy), in n=2 cases after initial mastectomy. The initial surgical procedure (p=0.008) and additional CIS (p=0.046) significantly influenced the rate of repeated surgeries, while tumour size, patient age and BPE did not (p=ns). CONCLUSIONS: Additional CIS was associated with a higher rate of repeated surgeries, whereas BPE had no influence.

Background parenchymal enhancement in breast MRI before and after neoadjuvant chemotherapy: correlation with tumour response.

OBJECTIVES: To correlate the decrease in background parenchymal enhancement (BPE) and tumour response measured with MRI in breast cancer patients treated with neoadjuvant chemotherapy (NAC). METHODS: One hundred and forty-six MRI examinations of 73 patients with 80 biopsy-proven breast cancers who underwent breast MRI before and after NAC were retrospectively analysed. All images were reviewed by two blinded readers, who classified BPE into categories (BEC; 1 = minimal, 2 = mild, 3 = moderate, 4 = marked) before and after NAC. Histopathological and morphological tumour responses were analysed and compared. RESULTS: The distribution of BEC 1/2/3/4 was 25/46/18/11 % before and 78/20/2/0 % after NAC. On average, BPE decreased by 0.87 BEC. Cohen's kappa showed substantial agreement (k = 0.73-0.77) before and moderate agreement (k = 0.43-0.60) after NAC and moderate agreement (k = 0.62-0.60) concerning the change in BEC. Correlating the change in BPE with tumour response, the average decrease in BEC was 1.3 in cases of complete remission, 0.83 in cases with partial response, 0.85 in cases with stable disease and 0.40 in cases with progressive disease. Correlation analysis showed a significant correlation between the decrease in BEC and tumour response (r = -0.24, p = 0.03). CONCLUSIONS: BPE decreased by, on average, 0.87 BEC following NAC for breast cancer. The degree of BPE reduction seemed to correlate with tumour response. KEY POINTS: • BPE decreases by an average of 0.87 categories under neoadjuvant chemotherapy. • The reduction of BPE following neoadjuvant chemotherapy correlates with the tumour response. • The classification of the BPE shows good agreement among trained readers.

Jaw-opening accuracy is not affected by masseter muscle vibration in healthy men.

There is a functional integration between the jaw and neck regions with head extension-flexion movements during jaw-opening/closing tasks. We recently reported that trigeminal nociceptive input by injection of hypertonic saline into the masseter muscle altered this integrated jaw-neck function during jaw-opening/closing tasks. Thus, in jaw-opening to a predefined position, the head-neck component increased during pain. Previous studies have indicated that muscle spindle stimulation by vibration of the masseter muscle may influence jaw movement amplitudes, but the possible effect on the integrated jaw-neck function is unknown. The aim of this study was to investigate the effect of masseter muscle vibration on jaw-head movements during a continuous jaw-opening/closing task to a target position. Sixteen healthy men performed two trials without vibration (Control) and two trials with bilateral masseter muscle vibration (Vibration). Movements of the mandible and the head were registered with a wireless three-dimensional optoelectronic recording system. Differences in jaw-opening and head movement amplitudes between Control and Vibration, as well as achievement of the predefined jaw-opening target position, were analysed with Wilcoxon's matched pairs test. No significant group effects from vibration were found for jaw or head movement amplitudes, or in the achievement of the target jaw-opening position. A covariation between the jaw and head movement amplitudes was observed. The results imply a high stability for the jaw motor system in a target jaw-opening task and that this task was achieved with the head-neck and jaw working as an integrated system.

Experimental masseter muscle pain alters jaw-neck motor strategy.

BACKGROUND: A functional integration between the jaw and neck regions has been demonstrated during normal jaw function. The effect of masseter muscle pain on this integrated motor behaviour in man is unknown. The aim of this study was to investigate the effect of induced masseter muscle pain on jaw-neck movements during a continuous jaw opening-closing task. METHODS: Sixteen healthy men performed continuous jaw opening-closing movements to a target position, defined as 75% of the maximum jaw opening. Each subject performed two trials without pain (controls) and two trials with masseter muscle pain, induced with hypertonic saline as a single injection. Simultaneous movements of the mandible and the head were registered with a wireless optoelectronic three-dimensional recording system. Differences in movement amplitudes between trials were analysed with Friedman's test and corrected Wilcoxon matched pairs test. RESULTS: The head movement amplitudes were significantly larger during masseter muscle pain trials compared with control. Jaw movement amplitudes did not differ significantly between any of the trials after corrected Wilcoxon tests. The ratio between head and jaw movement amplitudes was significantly larger during the first pain trial compared with control. CONCLUSIONS: Experimental masseter muscle pain in humans affected integrated jaw-neck movements by increasing the neck component during continuous jaw opening-closing tasks. The findings indicate that pain can alter the strategy for jaw-neck motor control, which further underlines the functional integration between the jaw and neck regions. This altered strategy may have consequences for development of musculoskeletal pain in the jaw and neck regions.

Difference in dose area product between analog image intensifier and digital flat panel detector in peripheral angiography and the effect of BMI.

PURPOSE: Comparison of dose area products (DAP) in diagnostic angiography procedures between an image intensifier (II) and a flat panel detector (FPD) angiography system and the evaluation of DAP/body mass index (BMI) dependency. MATERIALS AND METHODS: An image intensifier system or a flat panel detector system was used to perform 571 diagnostic angiographies (n = 328 and n = 243, respectively) of 5 different types: peripheral arterial, venous, single leg, abdominal and upper extremity. The results were retrospectively analyzed. The DAP, fluoroscopy time (t) and the number of series of the respective interventions as calculated by the respective machines was compared for all interventions and for the respective subtypes and machines. The BMI dependency was calculated separately for both machines for all interventions by subdividing the patients into 6 BMI classes defined by the WHO. RESULTS: The average DAP for all diagnostic interventions was 1958.9 cGy×cm2 (t = 384.6 s, n = 7.85 series) for the II and 2927.4 cGy×cm2 (t = 267.4 s, n = 7.02 series) for the FPD. Group-dependent differences ranged between + 21 and + 252 % when using the FPD system. After time standardization, the respective increases were found to be 120 % for the FPD system. The DAPs increased considerably in patients with higher BMIs (766.7 cGy × cm2 - 6892.6 cGy × cm2, II machine, 950.5 cGy × cm2 - 12 487.7 cGy × cm2, FPD machine) with a greater DAP gain seen for the FPD. The average duration of the interventions was higher using the II machine. CONCLUSION: The use of an FPD system led to higher DAP values compared to the II system in diagnostic angiographic procedures. In addition, increased BMI values led to higher DAPs, especially for the FPD machine. However, the average fluoroscopy times were shorter.

[MR aspect of the prostate in CPPS patients (chronic pelvic pain syndrome)]. / MR-Befundmuster der Prostata bei Patienten mit CPP Syndrom (chronic pelvic pain syndrome).

PURPOSE: To describe typical morphological patterns of abacterial prostatitis using magnetic resonance imagine (MRI) in chronic pelvic pain syndrome patients including spectroscopy. MATERIALS AND METHODS: 18 patients (age range between 25 and 67 years, average 46.2 years) with recurrent chronic pelvic pain syndrome for at least 3 months were evaluated clinically in the urological department and included if there were no suspicious findings from endorectal digital palpation and if their PSA values were < 5 ng/ml. A retrospective analysis of these 18 patients with 30 contrast-enhanced MRI investigations with endorectal coils in 28 of 30 cases was performed with a 1.5T MRI. T 2w signal intensity (SI) and spectroscopy data (9 / 18 patients) were acquired for the normal peripheral zone, the central zone, for the peripheral zone suspected of inflammation and for the muscle including SI ratios for the unaltered and the suspicious inflammatory peripheral zone. RESULTS: Typical MR patterns of signal alterations suspected of inflammation of CPPS patients were able to be detected as T 2w hypointense triangular, stringy (n = 12, 66.6 %) contrast-enhancing signal alterations without a nodular shape with well circumscribed margins of the capsula and without pericapsular signal alterations. In 6 patients changes also had a triangular but more homogeneous aspect (33.3 %). Three patients had an additional periurethral uptake (16.6 %). T 2w SI measurements and T 2w SI ratios showed much lower values for the peripheral zone suspected of inflammation as compared to the normal peripheral zone of the prostate (277.29 STD 77.5 to 432.9 STD 112.02 and 4.94 STD 1.47 to 7.58 STD 2.01 respectively). The spectroscopic analysis of the signal alterations suspected of inflammation showed normal Cholin+Creatin/Citrate SI ratio values in 3 patients (SI < 0.5), ratios suspected of low grade cancer in 3 patients (SI 0.5 and < 0.7) and ratios suspected of intermediate grade prostate cancer in 3 patients (SI > 0.7 and < 3.0). CONCLUSIONS: We saw typical MR patterns in CPPS patients. However, spectroscopy can mimic findings of cancer so that the knowledge of typical morphological patterns and a solid clinical evaluation play a major role in the diagnosis of CPPS.

Percutaneous vascular interventions in the superficial femoral artery. A review.

The superficial femoral artery (SFA) is a frequent target of atherosclerotic disease predominantly in the proximal section near the bifurcation to the deep femoral artery and in the distal section where the adductor muscles tend to compress the artery. In the past, SFA revascularization was the domain of vascular surgery (femoropopliteal and femorodistal bypasses). However, with the development of endovascular treatment and advancing techniques as well as more sophisticated stenting material and balloons, endovascular treatment is nowadays not just a treatment option but, in most cases, preferable at least as initial revascularization procedure in the treatment of peripheral artery vascular disease. In the last years, many efforts have been made to fight restenosis in revascularized artery segments after stenting and/or angioplasty. This article aims to give a review on this topic including the most recent experience with the various latest revascularization techniques such as drug eluting stents, coated stent grafts, brachytherapy, cryoplasty, cutting balloons, and drug coated balloons.

A comparison of itraconazole versus fluconazole as maintenance therapy for AIDS-associated cryptococcal meningitis. National Institute of Allergy and Infectious Diseases Mycoses Study Group.

This study was designed to compare the effectiveness of fluconazole vs. itraconazole as maintenance therapy for AIDS-associated cryptococcal meningitis. HIV-infected patients who had been successfully treated (achieved negative culture of CSF) for a first episode of cryptococcal meningitis were randomized to receive fluconazole or itraconazole, both at 200 mg/d, for 12 months. The study was stopped prematurely on the recommendation of an independent Data Safety and Monitoring Board. At the time, 13 (23%) of 57 itraconazole recipients had experienced culture-positive relapse, compared with 2 relapses (4%) noted among 51 fluconazole recipients (P = .006). The factor best associated with relapse was the patient having not received flucytosine during the initial 2 weeks of primary treatment for cryptococcal disease (relative risk = 5.88; 95% confidence interval, 1.27-27.14; P = .04). Fluconazole remains the treatment of choice for maintenance therapy for AIDS-associated cryptococcal disease. Flucytosine may contribute to the prevention of relapse if used during the first 2 weeks of primary therapy.

Lack of effect of erythromycin and ketoconazole on the pharmacokinetics and pharmacodynamics of steady-state intranasal levocabastine.

The single-dose effects of the cytochrome P-450 inhibitors erythromycin and ketoconazole on the steady-state pharmacokinetics and electrocardiographic repolarization pharmacodynamics of intranasal levocabastine, a potent and selective H1-receptor antagonist, were evaluated in healthy young male subjects. Two randomized, open-label, placebo-controlled, two-way crossover studies were performed. Levocabastine nasal spray was administered as two sprays per nostril (0.05 mg/spray) twice daily (for a total daily dose of 0.4 mg) for 6 days. On Day 7, a single dose of 0.2 mg was administered followed immediately by a single dose of either oral placebo, erythromycin 333 mg, or ketoconazole 200 mg. In all treatment groups, levocabastine was rapidly absorbed, with peak plasma concentrations reached at approximately 3 hours in the erythromycin study and 2.8 hours in the ketoconazole study. The mean terminal half-life was approximately 45 and 44 hours, respectively. In both studies, mean steady-state plasma concentrations and pharmacokinetics of levocabastine following the single doses of erythromycin or ketoconazole were not significantly different from corresponding values seen with the concomitant administration of the placebo. No clinically significant mean changes from baseline in QT or QTc (QT corrected for heart rate) intervals occurred in any of the treatment groups, and none of the subjects in either study experienced abnormally prolonged QTc intervals. Intranasal levocabastine was well tolerated, with no difference in the incidence of adverse events between treatment groups in either study; adverse events were generally mild in severity. Since levocabastine undergoes only minimal hepatic metabolism and is not a substrate for or an inhibitor of cytochrome P-450, the likelihood of systemic drug interactions with drugs affecting the cytochrome P-450 system is minimal.

A multicenter, investigator-blinded, randomized comparison of oral levofloxacin and oral clarithromycin in the treatment of acute bacterial sinusitis.

A multicenter, investigator-blinded, randomized, parallel-group study was conducted to compare oral levofloxacin 500 mg once/day for 14 days with clarithromycin 500 mg twice/day for 14 days in the treatment of acute bacterial sinusitis. Of 216 adult outpatients randomized to treatment, 190 were evaluable for efficacy. The primary efficacy measure was clinical response, based on resolution of signs and symptoms 2-5 days after therapy. A secondary efficacy measure was relapse rate 1 month after therapy. Among evaluable patients, clinical success rates (cured or improved) were 96.0% and 93.3% for levofloxacin (L) and clarithromycin (C), respectively (95% CI -9.2%, 3.7%). The confidence interval (CI) for treatment difference (C-L) included zero and its upper limit was less than 15%, indicating that levofloxacin was as effective as clarithromycin. In all, 4.1% of patients receiving levofloxacin and 7.2% receiving clarithromycin had a relapse of symptoms 1 month after therapy (95% CI-12.2%, 3.2%). Long-term success (initial success, absence of relapse at 1 month, no further antibacterial therapy 2-5 days after therapy) was 79.2% in the levofloxacin group and 76.4% in the clarithromycin group (95% CI -14.7%, 9.0%). Based on investigator-assessed treatment-emergent adverse events, overall tolerability of the drugs was similar, except for a higher frequency of taste perversion and diarrhea in the clarithromycin group. Levofloxacin had an advantage over clarithromycin based on two quality-of-life (QOL) parameters: number of times taking other drugs for targeted medical conditions and mean total cost of these drugs. No statistical significance was found in other QOL variables. These findings suggest that the efficacy and tolerability of levofloxacin 500 mg once/day are comparable with those of clarithromycin 500 mg twice/day in the treatment of acute bacterial sinusitis.

Laser in situ keratomileusis for moderate and high myopia and myopic astigmatism.

OBJECTIVE: This study evaluated the predictability, stability, and safety of laser in situ keratomileusis (LASIK) in myopia and myopic astigmatism. DESIGN: The study design was a prospective, unmasked, nonrandomized clinical trial. PARTICIPANTS: Participating were 25 patients with myopia (37 eyes) with astigmatism of less than 1.00 diopter (D), divided into 3 subgroups (-5.00 to -9.90 D, 8 eyes; -10.00 to -14.90 D, 10 eyes; -15.00 to -29.00 D, 19 eyes), and 37 patients with myopia (56 eyes) with corneal astigmatism of 1.00 to 4.50 D, divided into 3 subgroups (-5.00 to -9.90 D, 12 eyes; -10.00 to -14.90 D, 24 eyes; -15.00 to -29.00 D, 20 eyes). INTERVENTION: LASIK was performed using the Automatic Corneal Shaper and the Keracor 116 excimer laser. MAIN OUTCOME MEASURES: Visual acuity, manifest refraction, central corneal islands, ablation decentration, and patient satisfaction were measured. RESULTS: At 12 months, predictability, regression between 1 and 12 months, uncorrected visual acuity (UCVA), loss of two or more lines of corrected visual acuity, and patient satisfaction of the spherical (toric) groups are reported. Subgroups -5.00 to -9.90 D: 100% (75%) +1.00 D; regression less than or equal to 1.00 D in 100% (91.7%); UCVA greater than or equal to 20/40 in 87.5% (70%); none lost two or more lines; 100% (84%) highly satisfied. Subgroups -10.00 to -14.90 D: 60% (78.3%) +/-1.00 D; regression less than or equal to 1.00 D in 100% (87%); UCVA greater than or equal to 20/40 in 77.8% (86.4%); 10% (4.3%) lost two lines; 90% (91%) highly satisfied. Subgroups -15.00 to -29.00 D: 38.9% (21.4%) +/-1.00 D; regression less than or equal to 1.00 D in 72.2% (64.3%); UCVA greater than or equal to 20/40 in 33.3% (40%); 5.6% (7.1%) lost two lines; 78% (50%) highly satisfied. Differences of predictability and change of manifest refraction between subgroups of -5.00 to -9.90 D and -15.00 to -29.00 D were statistically significant. Central islands (decentrations) were observed in 17% (5.6%) of eyes of the spherical and in 16% (4.1%) of the toric group. Overall, the corneal interface was visible in 8.2%. CONCLUSIONS: The LASIK method used in this study showed stability of manifest refraction and adequate uncorrected central visual acuity in a large percentage of patients with myopia up to -15.00 D. Corneal stability was not as uniform. Central corneal islands were observed in a sizable minority of patients despite pretreatment. For myopia greater than 15.00 D, accuracy and patient satisfaction were sufficiently poor to advise against using the authors' treatment technique in these groups. Visually significant microkeratome and laser-related problems were noted in a smaller percentage of patients. Patients with astigmatism correction were less pleased with results than were patients who received spherical corrections.

[Laser in situ keratomileusis (LASIK) for correction of myopia]. / Laser-in-situ-Keratomileusis (LASIK) zur Myopiekorrektur.

BACKGROUND: Laser in situ keratomileusis (LASIK) preserves the corneal epithelium and Bowman's layer, which theoretically minimizes corneal scarring. We, therefore, evaluated the accuracy, stability and safety of LASIK in moderate to high myopia. PATIENTS AND METHODS: Eighty-five eyes (50 patients) treated using the Automatic Corneal Shaper and the Keracor 116 excimer laser were followed up for 1, 6, and 12 months. Spectacle refraction, visual acuity and rate of retreatments were evaluated. RESULTS: At 12 months, results were as follows: Myopia -5 to -9.9 D (n = 20); 85% within 1 D; regression between one and 12 months < or = 1 D in 90%; uncorrected acuity 20/40 or better in 75%; no loss of two or more lines of visual acuity. Myopia -10 to -14.9 D (n = 33): 73% within 1 D; regression between 1 and 12 months < or = 1 D in 91%; uncorrected acuity 20/40 or better in 79%; 6.1% lost two lines of visual acuity. Myopia -15 to -29 D (n = 32): 31% within 1 D; regression between one and 12 months < or = 1 D in 63%; 6.3% lost two or more lines of visual acuity. Reoperations were performed in two eyes (2.4%) due to epithelial ingrowth or folds of the flap, and in four eyes (4.7%) because of undercorrections or "central islands". CONCLUSIONS: LASIK is an accurate and stable procedure for correcting myopia of -5 to -15 D. In higher myopia, however, results are not satisfactory.

Laser in situ keratomileusis to correct myopia of -6.00 to -29.00 diopters.

BACKGROUND: Photorefractive keratectomy can cause corneal scarring and visual loss in highly myopic eyes. We evaluated laser in situ keratomileusis (LASIK) because it has the theoretical advantage of preserving both the corneal epithelium and Bowman's layer. METHODS: In a prospective study, LASIK was performed in 62 myopic eyes (42 patients) using the Automatic Corneal Shaper (Chiron Vision) and the Keracor 116 excimer laser (Chiron Technolas). We measured refraction and visual acuity, and evaluated corneal topography (TMS 1) and corneal clarity after 4 to 8 weeks and 4 to 6 months. RESULTS: Four- to 6-month follow up was completed in 51 eyes. The mean preoperative spherical equivalent refraction was -14.80 diopters (D) (range, -6.00 to -29.00 D). Postoperatively, the mean deviation from the target refraction was -1.70 D (range, -9.00 to +2.50 D) at 4 to 8 weeks and -1.90 D (range, -9.50 to +2.25 D) at 4 to 6 months. At 4 to 6 months, 19 eyes (37%) were within +/- 0.50 D of the target refraction, 24 (47%) within +/- 1.00 D, 33 (65%) within +/- 2.00 D, and 40 (78%) within +/- 3.00 D. From 4 to 8 weeks to 4 to 6 months, the mean regression of myopia was -0.20 D (0.50 D or less in 24 eyes [47%], 1.00 D or less in 32 [63%], and 2.00 D or less in 42 [82%]). In six eyes (12%), the stromal interface was not visible, in 38 (74%) it was barely visible, and in seven (14%) it was clearly visible. Corneal topography revealed only small variations in clear-zone size and dioptric value, demonstrating a very stable correction 4 to 6 months postoperatively. CONCLUSIONS: LASIK may be a safe and effective procedure to correct high myopia. Further research is required to develop satisfactory microkeratome technology, effective laser algorithms, and to determine long-term stability of refraction.

[Correction of myopia using laser in situ keratomileusis (LASIK)]. / Myopiekorrektur mittels Laser in situ Keratomileusis (LASIK).

BACKGROUND: In contrast to photorefractive keratectomy (PRK), the corneal epithelium and Bowman's layer are preserved in LASIK. Thus, there should be less scarring and regression after LASIK than after PRK. PATIENTS: Between December 1993 and October 1995, we treated 113 eyes (66 patients). The Automated Corneal Shaper and the Keracor 116 excimer laser were used. We evaluated refraction, visual acuity and corneal topography. RESULTS: To date, 61 eyes reached six months follow up. Mean preoperative refraction was -14.3 D (-3.3 to -29 D; SD = 7). Mean deviation from target refraction was -1.4 D (-9.5 to +2.5 D; SD = 2.7) at six months. 34% were within +/-0.5 D of target refraction, 46% within +/-1 D, 67% within +/-2 D, and 82% within +/-3 D. Mean change of refraction ("regression") from one to six months postoperatively was +0.13 D (-7.5 to +8 D; SD = 2.1). Refractive change was < 0.5 D in 51%, < 1 D in 66%, < 2 D in 84%, and < 3 D in 89%. In 88% of eyes, the corneal interface was not or just barely visible, while it was clearly visible in 12%. No scars were observed. CONCLUSIONS: Our results indicate that LASIK is an effective procedure in the correction of high myopia. The incidence of scar formation and regression is considerably lower than after PRK.