PURPOSE: To evaluate the efficacy and safety of BOTULAX® in subjects with essential blepharospasm.METHODS: In this study, a total of 250 subjects with essential blepharospasm were enrolled at 15 investigational sites and a total of 220 subjects completed the study. The efficacy and safety were evaluated at weeks 4 and 16 after treatment compared with baseline. In total, 240 subjects were enrolled, treated with the investigational product, and evaluable for the primary efficacy assessment at week 4 after treatment; these subjects were included in the intention-to-treat (ITT) population. With the ITT set as the main efficacy set, efficacy assessment included Jankovic rating scale (JRS), functional disability score, investigator evaluation of global response and quality of life. Safety assessment including the incidence of adverse events was also performed.RESULTS: In terms of the primary efficacy endpoint (i.e., change in JRS total score at week 4 after treatment from baseline [ITT set]), mean change indicated a statistically significant reduction (p < 0.0001) and demonstrated the non-inferiority of the test drug to similar drugs. In terms of the secondary efficacy endpoints, mean change in JRS total score at week 16 after treatment and mean change in functional disability score at weeks 4 and 16 after treatment both exhibited a statistically significant reduction compared with baseline (p < 0.0001 for all). Among the 249 subjects treated with the investigational product in this study, 44 (17.67%) experienced 76 treatment emergent adverse events but no serious adverse events were observed.CONCLUSIONS: Based on the study results, BOTULAX® is considered to be an effective and safe treatment for essential blepharospasm.

PURPOSE: To identify factors influencing the ablation center and to evaluate the size of the ablation zone after PRK and LASIK using Technolas 217 C. METHODS: This study examined the results of refractive surgery using Technolas 217 C Excimer laser with eye tracking system in 69 eyes, of which 31 underwent PRK and 38 LASIK. The ablation zone and degree of decentration were determined through corneal topography. We divided the eyes into two groups according to the degree of decentration: less than 0.5 mm as the first group, and from 0.5 to 1.0 mm as the second. The ablation zone diameter in topography was compared with the programmed preoperative optical zone. RESULTS: The only factor influencing the ablation center in the PRK group was preoperative spherical equivalent(p=0.016), and no factor influenced the ablation zone in the LASIK group. In both groups, the long axis of the ablation zone was longer than that of the programmed optical zone(p=0.003), while the short axis was shorter (p=0.001). CONCLUSIONS: After refractive surgery using Technolas 217 C Excimer laser with eye tracking system, there was no clinically significant decentration. With greater preoperative spherical equivalent, more decentered ablation was noted in the PRK group. The topographical long axis of the ablation zone was longer than that of the programmed ablation zone, while the short axis of the ablation zone was shorter. During refractive surgery, we should be aware of the possibility that the short axis of the postoperative ablation zone may be shorter than that of the programmed preoperative optical zone.
Axis ; Corneal Topography ; Keratomileusis, Laser In Situ ; Lasers, Excimer ; Refractive Surgical Procedures*

PURPOSE: To describe a low-grade infection of hydroxyapatite orbital implant diagnosed by 99mTc-labeled leukocyte scintigraphy. METHODS: A 34-year-old man diagnosed as phthisis bulbi due to corneoscleral laceration on left eye had been treated with evisceration and hydroxyapatite orbital implant insertion. After drilling for ocular prosthesis, the patient did not have any symptom for 3 years and 5 months. He presented with socket pain, erythematous lid swelling, severe conjunctival discharge. There was no improvement of symptom despite conservative treatment for 3 weeks. MRI revealed no abnormalities so 99mTc-labeled leukocyte scintigraphy was performed. RESULTS: Scintigraphy showed a dense accumulation of labeled leukocyte at the implant site. After diagnosed as hydroxyapatite orbital implant infection, orbital implant was removed and silicon sphere implantation was done. After operation, the inflammation signs disappeared. CONCLUSIONS: 99mTc-labeled leukocyte scintigraphy is a useful technique in diagnosing low-grade infection of hydroxyapatite orbital implant undetected using conventional imaging method such as MRI.
Adult ; Durapatite* ; Eye, Artificial ; Humans ; Inflammation ; Lacerations ; Leukocytes* ; Magnetic Resonance Imaging ; Orbital Implants ; Radionuclide Imaging* ; Silicones ; Technetium*

PURPOSE: We investigated the effect of Mitomycin C (MMC) on corneal wound healing after excimer laser photorefractive keratectomy (PRK) in rabbits. METHODS: Excimer laser PRK was performed on 11 white rabbits. Right eyes underwent intraoperative application of 0.02% MMC (MMC group) and left eyes underwent intraoperative application of BSS (control group) for 2 minutes. Corneal opacity was described with slit-lamp biomicroscope at 1, 2, 3, and 4 weeks after PRK. Endothelial cell count and corneal thickness were measured at preoperative period and postoperative 3 weeks. RESULTS: Subepithelial opacity was grade 2 in MMC group and control group at postoperative 1 week. Subepithelial opacity was grade 2 in 1 of 10 eyes of MMC group and was also grade 2 in 8 of 10 eyes of control group at postoperative 2 weeks. Epithelial healing was delayed in MMC group. Corneal thickness showed no relevant difference in MMC group and control group between preoperative and postoperative periods. Endothelial cell count decreased in postoperative period in MMC group while endothelial cell count showed no relevant difference in control group between preoperative and postoperative periods. CONCLUSIONS: The application of 0.02% MMC after PRK for 2 minutes reduced corneal haze. However, delayed healing of corneal epithelium and damage of endothelium can be induced if MMC is not washed thoroughly.
Corneal Opacity ; Endothelial Cells ; Endothelium ; Epithelium, Corneal ; Lasers, Excimer* ; Mitomycin* ; Photorefractive Keratectomy* ; Postoperative Period ; Preoperative Period ; Rabbits ; Wound Healing* ; Wounds and Injuries*

PURPOSE: To report one case of juvenile xanthogranuloma invading iris, which resulted in secondary glaucoma due to hyphema. METHODS: A 6-month-old girl with no history of previous trauma visited the hospital complaining of severe injection in her left eye for 3 days. The initial IOP of the affected eye was 35 mmHg, showing gross hyphema. The eye did not show any improvement despite 3 days of conservative treatment. Therefore, the diffuse membranous tissue on iris was removed by the anterior chamber irrigation. The histologic and immunologic study was done on the removed tissue. RESULTS: On the third day after operation, the IOP of the affected eye was 13mmHg. The doses of steroid eye drops and oral steroid were reduced. On the seventh day after operation, the IOP of left eye was 17 mmHg without any specific findings. The pathologic findings showed proliferative histiocytes containing acidophillic cytoplasma with abundant vacuoles. Moreover, the tissue reacted with CD 68 in immunohistochemical stain. The tissue did not show any change in S-100 protein, CD 1a, and Cytokeratin. CONCLUSIONS: The authors report the first case of juvenile xanthogranuloma which represented as secondary glaucoma due to spontaneous hyphema without any trauma history.
Anterior Chamber ; Female ; Glaucoma ; Histiocytes ; Humans ; Hyphema ; Infant ; Iris* ; Keratins ; Ophthalmic Solutions ; S100 Proteins ; Vacuoles ; Xanthogranuloma, Juvenile*

After hemiglossectomy due to tongue cancer, such factors as mobility, sensation, volume and the shape of the tongue are critical elements for successful rehabilitation. As long as there is a residual segment of mobile tongue with an intact motor nerve supply, the mobility of native tongue can be preserved by using tissue with thin, pliable and sensory potential. The residual tongue motion can be maximized by separating the reconstruction of mobile tongue from the reconstruction of the floor of mouth. Six patients who underwent significant glossectomy for squamous cell cancer were reconstructed with a bilobed design of sensate radial forearm flap. One lobe of the flap is used to restore the shape and volume of the tongue, while the other lobe is used to resurface the floor of the mouth. There were no flap failure and fistula formation. In all patients, the tongue mobility was preserved and the earliest recovery of sensation was noted 5 weeks following the surgery. The articulation was good enough for them to perform daily activities. With the bilobed design, we can maximize the mobility of the residual tongue by preventing tethering of the root of tongue to the inner table of the mandible. In this article e present our successful experiences with this method, especially in view of mobility and sensation.
Fistula ; Forearm* ; Free Tissue Flaps* ; Glossectomy ; Humans ; Mandible ; Mouth ; Mouth Floor ; Neoplasms, Squamous Cell ; Rehabilitation ; Sensation ; Tongue ; Tongue Neoplasms

Renal cell carcinoma is extremely uncommon in children. But this neoplasm should be considered in the differential diagnosis of hematuria and/or abdominal mass in children. We present a case of renal cell carcinoma in an 11-year-old girl which was confirmed pathologically.
Carcinoma, Renal Cell* ; Child ; Diagnosis, Differential ; Female ; Hematuria ; Humans

To evaluate the role of epidermal growth factor receptor(EGF-R) and transforming growth factor alpha (TGF-alpha) in transitional cell carcinoma of the urinary bladder, immunohistochemical studies using monoclonal antibodies to the human EGF-R and TGF-alpha were performed on formalin fixed,paraffin-embedded tissue with the urothelium extracted from patients with TCC(59 cases) and non-TCC(13 cases). EGF-R was expressed in the outer, middle and basal layers of TCC and non-TCC urothelium. The staining intensity of EGF-R in the outer layer was not different between TCC and non-TCC urothelium. The strong staining intensity of EGF-R in the outer, middle and basal layers was noted in 5(14%), 4(11 %) and 5(14%) cases, respectively in the low grade TCC(35 cases of grade I and II ), however all the layers of 13(54%) cases of the high grade TCC(24 cases of grade III and IV) showed strong staining intensity. The strong staining intensity of EGF-R in the three layers of the superficial tumors(34 cases of Ta and T1) was noted in 6(18%), 5(15%) and 5(15%) cases, whereas 12(48%), 12(48%) and 13 (52% ) cases in the invasive tumors(25 cases of T2, T3, T4). TGF-alpha was expressed in 27(46%) cases of TCC and 11(85%) cases of non-TCC urothelium. TGF-alpha was expressed in 24(69%), 15 (43%) and 12(34% ) cases in the three layers of low grade TCC, respectively and only 3(12 %) cases in the high grade TCC. TGF-alpha expression in the outer, middle and basal layers of the superficial TCC was noted in 22(65 %), 14(41%) and 12(35%) cases, respectively, whereas that of the invasive TCC was 6 (20%), 4(16%) and 3(12%) cases, respectively. These results suggest that the distribution of EGF-R in the tumor cells are not an important factor. However, the binding capacity of EGF-R to EGF and TGF-alpha may be an important change in the carcinogenesis of the bladder TCC and the expression intensity of EGF-R and TGF-alpha in TCC cells may be an important factor to determine the biological behavior of the bladder TCC.
Antibodies, Monoclonal ; Carcinogenesis ; Carcinoma, Transitional Cell* ; Epidermal Growth Factor* ; Formaldehyde ; Humans ; Receptor, Epidermal Growth Factor* ; Transforming Growth Factor alpha ; Urinary Bladder* ; Urothelium

Prune belly syndrome is a rare anomaly complex associated with absence of abdominal muscle combined with urinary tract abnormalities. We have encountered stillbirth female with severely distended abdomen without external genitalia end anus who was Finally confirmed as prune belly syndrome by an autopsy. Herein we report a case with review of literature.
Abdomen ; Abdominal Muscles ; Anal Canal ; Autopsy ; Female ; Genitalia ; Humans ; Prune Belly Syndrome* ; Stillbirth ; Urinary Tract

We experienced a case of transureteroureterostomy in a single kidney with multiple distal ureteral strictures. The patient had received nephrectomy due to staghorn calculi 14 years ago. We have utilized the abandoned ureter from the transureteroureterostomy with stenting. We have confirmed good drainage through the anastomosed ureter by radiological imaging. No other complications were observed except Pseudomonas urinary tract infection. Thereby we report this unique procedure of transureteroureterostomy using the 14-year-age abandoned ureter.
Calculi ; Constriction, Pathologic ; Drainage ; Humans ; Kidney ; Nephrectomy ; Pseudomonas ; Stents ; Ureter ; Urinary Tract Infections