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Acute coronary syndrome is a rare complication of vasculitis. We present a case of fulminant medium-vessel vasculitis, most likely PAN, complicated by STEMI and stroke, that was successfully treated with percutaneous revascularization, high-quality stroke care, and immunosuppression. This case highlights the importance of prompt diagnosis and treatment of vasculitis and the recognition of coronary and cerebral ischemia as potentially serious complications.
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PURPOSE: To evaluate the rotational stability of a toric extended depth of focus (EDOF) intraocular lens (IOL), using either slit lamp evaluation or image-processing software. SETTING: Three clinical practices in the USA. DESIGN: Prospective unmasked randomized clinical trial. METHODS: Subjects presenting for routine cataract surgery that were interested in improved near vision received toric EDOF lenses (TECNIS Symfony® Toric) in both eyes. The measures of interest in the current analysis were the change in orientation of the IOL between 1 day, 1 month and 3 months postoperative. Orientation was measured at the microscope on the day of surgery, and with the slit lamp at all other visits. Day 1, 1-month and 3-month images of the lens orientation were captured with a slit lamp camera. Differences in orientation were recorded and analyzed. RESULTS: A total of 150 eyes had IOL orientation data available. Image analysis showed mean absolute lens orientation changes from 1 day to 1 month and 3 months of less than 2 degrees. The percentage of lenses exhibiting rotation of ≤5 degrees between any measured time points was 97% or higher. Results were similar, but significantly more variable, when IOL orientation was measured at the slit lamp. CONCLUSION: The toric EDOF lens evaluated here demonstrated rotational stability that exceeded the prior ANSI standard. The best method to determine IOL orientation changes was through image analysis. .
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PURPOSE: To evaluate the defocus curve and patient satisfaction after implantation of an extended depth of focus (EDOF) toric IOL when both eyes were targeted for emmetropia and when the non-dominant eye was targeted for mini monovision (-0.50D). METHODS: A prospective unmasked randomized clinical trial in three clinical practices in the USA. Subjects presenting for routine cataract surgery were assigned to one of two groups, both receiving bilateral toric EDOF lenses. One group had the non-dominant eye targeted for slight myopia (-0.50D). Measures of interest were the postoperative defocus curve and reported patient satisfaction and visual disturbances. RESULTS: Questionnaire and defocus curve data were available from 37 subjects in the Emmetropia group, while the mini monovision group included questionnaire data from 39 subjects and valid defocus curve data from 14 subjects. Mini monovision subjects had significantly better VA (a half line to a line better, p < 0.05), from a defocus of -1.50 D to -3.00 D. Reported spectacle wear and satisfaction were not significantly different between groups at any distance, but more patients in the mini monovision group reported the ability to function comfortably without glasses at near and overall (near p = 0.02, overall p < 0.01). Halos and starbursts were the two phenomena reported most often for both groups, with reported starbursts slightly more common in the mini monovision group. CONCLUSIONS: A slightly myopic correction in the non-dominant eye improved binocular near vision by 0.5 to 1.0 lines based on defocus curve data. Patients reported better functional vision, but with a slight increase in reported starbursts in the mini monovision group.
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Purpose: To compare, in a masked manner, a novel cross-linked hyaluronic acid ocular bandage gel (OBG) versus standard-of-care bandage contact lens (BCL) plus artificial tears with respect to safety and effectiveness in healing epithelial defects created for photorefractive keratectomy (PRK). Methods: This was a randomized, reading center-masked, exploratory study. Forty-five patients (myopic without significant anisometropia) scheduled for bilateral PRK (9-mm epithelial defect) were randomized post-PRK to treatment with OBG 8 times daily for 3 days, followed by 4 times daily for 11 days (Group 1); OBG 4 times daily for 14 days (Group 2); or BCL and artificial tears (Control). A masked reading center used image analysis of digital slit lamp photos of the fluorescein-stained cornea to evaluate defect size during the 14-day postoperative follow-up period. Effectiveness endpoints were (1) time to complete closure of the corneal defect and (2) proportion of patients with complete healing on day 3 postoperatively, whose defect remained closed. Safety assessments included findings for adverse events and vision, Standard Patient Evaluation of Eye Dryness (SPEED™) Questionnaire, slit lamp, intraocular pressure, and fundus examinations. Results: The proportion of patients with complete healing at 3 days was 73.3%, 86.7%, and 66.7% of patients in Groups 1, 2, and Control, respectively. On day 2, the mean wound size was 6%-26% smaller in Groups 1 and 2 compared with Control. No safety concern arose. SPEED scores were not significantly different across groups. Conclusion: OBG offers a well-tolerated and effective therapy for quickly reepithelializing the cornea following trauma, disease, or surgery.
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Adjuvantes Imunológicos/farmacologia , Bandagens/efeitos adversos , Ácido Hialurônico/farmacologia , Miopia/cirurgia , Ceratectomia Fotorrefrativa/métodos , Adjuvantes Imunológicos/administração & dosagem , Adjuvantes Imunológicos/efeitos adversos , Adulto , Bandagens/estatística & dados numéricos , Estudos de Casos e Controles , Lentes de Contato/efeitos adversos , Córnea/diagnóstico por imagem , Córnea/patologia , Feminino , Fluoresceína/metabolismo , Humanos , Ácido Hialurônico/administração & dosagem , Ácido Hialurônico/efeitos adversos , Lubrificantes Oftálmicos/administração & dosagem , Masculino , Pessoa de Meia-Idade , Cuidados Pós-Operatórios/estatística & dados numéricos , Estudos Prospectivos , Reepitelização/efeitos dos fármacos , Segurança , Lâmpada de Fenda , Resultado do Tratamento , Acuidade Visual/efeitos dos fármacos , Cicatrização/fisiologiaRESUMO
PURPOSE: To present outcomes of the United States Food and Drug Administration premarket approval clinical trial of small-incision lenticule extraction (SMILE) for the correction of myopia and astigmatism. DESIGN: Prospective, multicenter clinical trial. PARTICIPANTS: The study included 357 eyes of 357 patients treated with SMILE (50 for myopia and 307 for myopia with astigmatism). Preoperative sphere ranged between -1.00 and -10.00 diopters (D), with manifest spherical equivalent (MSE) of up to -11.50 D and refractive cylinder of up to -3.00 D. METHODS: -Participants were followed up for 12 months. Corrected distance visual acuity (CDVA) and uncorrected distance visual acuity (UDVA), stability of the manifest refraction, and vector analysis of refractive cylinder are presented for the 307 eyes treated for myopia with astigmatism. Adverse events (AEs) are presented for all 357 eyes. MAIN OUTCOME MEASURES: Corrected distance visual acuity, uncorrected distance visual acuity, manifest refraction, astigmatic outcomes, and adverse events. RESULTS: Of the 307 astigmatic eyes enrolled in the study, 304 were treated successfully. In 3 eyes, the procedure was aborted because of intraoperative suction loss. The mean MSE reduced from -5.39±2.30 D at baseline to -0.01±0.24 D at 12 months. Of all eyes, 95.3% were within 0.50 D of emmetropia at 12 months. The percentage of eyes with UDVA of 20/20 or better was 89.0%. No loss of 2 or more lines of CDVA was observed at the 12-month visit. The refractive cylinder reduced from -1.53±0.70 D at baseline to -0.18±0.31 D at 12 months. The mean correction ratio of refractive cylinder was 0.96±0.16 and a slight undercorrection was apparent for higher attempted corrections of astigmatism. Three intraoperative AEs associated with difficult lenticule removal and resultant cap tear occurred, and all resolved without sequelae at postoperative day 1. During the postoperative period, 8 AEs were recorded, but none of them had significant consequences. CONCLUSIONS: Small-incision lenticule extraction for the treatment of myopia and astigmatism was safe and effective, and the reported AEs had no significant impact on visual acuity. Slight undercorrection of refractive cylinder requires further attention.
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Substância Própria/cirurgia , Cirurgia da Córnea a Laser/métodos , Lasers de Excimer/uso terapêutico , Microcirurgia/métodos , Miopia/cirurgia , United States Food and Drug Administration , Acuidade Visual , Adulto , Substância Própria/patologia , Topografia da Córnea , Feminino , Humanos , Masculino , Miopia/fisiopatologia , Período Pós-Operatório , Estudos Prospectivos , Resultado do Tratamento , Estados Unidos , Adulto JovemRESUMO
PURPOSE: To compare uncorrected distance visual acuity (UDVA) and patient-reported outcomes with a new silicone corneal shield and a conventional bandage contact lens (BCL) after photorefractive keratectomy (PRK). SETTING: Stanford Eye Laser Center (Palo Alto, California) and Slade & Baker Vision (Houston, Texas). DESIGN: Prospective randomized cohort study. METHODS: Standardized bilateral wavefront-guided or wavefront-optimized PRK was performed in 25 patients with myopia. Each patient's dominant eye was randomized to either a silicone corneal shield or a conventional BCL, which was placed at the conclusion of surgery. The contralateral eye was assigned the other intervention. The UDVA and patient-reported outcomes were measured preoperatively, 1 hour after surgery, and at 1, 2, 3, 4, and 7 days postoperatively. RESULTS: At 1 day postoperatively, the mean logarithm of the minimum angle of resolution (logMAR) UDVA was 0.04 ± 0.16 (SD) in the silicone corneal shield group and 0.29 ± 0.22 in the BCL group (P < 0.01). At 7 days postoperatively, the mean logMAR UDVA was 0.09 ± 0.17 in the silicone corneal shield group and 0.23 ± 0.24 in the BCL group (P = .01). At 1 day through 3 days postoperatively, the patients reported greater pain, discomfort, foreign body sensation, and heavy eyelid in the eye with the silicone corneal shield. There was no statistically significant difference in the survey outcomes between the two groups at 4 days and 7 days postoperatively. CONCLUSIONS: The new silicone corneal shield was safe and effective, with faster visual recovery and a trend toward quicker epithelialization; however, it might be less comfortable than a conventional BCL.
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Lentes de Contato Hidrofílicas , Aberrações de Frente de Onda da Córnea/terapia , Lasers de Excimer/uso terapêutico , Miopia/cirurgia , Elastômeros de Silicone , Acuidade Visual , Aberrometria , Adulto , Bandagens , Sensibilidades de Contraste , Aberrações de Frente de Onda da Córnea/etiologia , Aberrações de Frente de Onda da Córnea/fisiopatologia , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Ceratectomia Fotorrefrativa , Estudos Prospectivos , Desenho de Prótese , Refração Ocular/fisiologia , Reoperação , Privação Sensorial , Adulto JovemRESUMO
PURPOSE: To compare the visual and refractive outcomes with a diffractive toric extended depth-of-focus (EDOF) intraocular lens (IOL) when both eyes are targeted for emmetropia and the nondominant eye is targeted for slight myopia. SETTING: Three clinical practices, United States. DESIGN: Prospective case series. METHODS: Patients having routine cataract surgery with bilateral Tecnis Symfony toric EDOF IOL implantation were assigned to 1 of 2 groups. In 1 group, the nondominant eye was targeted for -0.50 diopter (D) (mini-monovision). Assessments included uncorrected monocular and binocular visual acuities (logarithm of the minimum angle of resolution) at distance (4 m), intermediate (66 cm), and near (40 cm) and the postoperative residual refractive error. RESULTS: Forty patients were enrolled in each group, with 1 dropout. The mean postoperative residual refractive astigmatism was 0.25 D in both groups, with no statistically significant difference. The mean residual refractive astigmatism was 0.50 D or lower in 92% of eyes (72/78) in the mini-monovision group and 95% of eyes (74/78) in the emmetropia group 3 months postoperatively. The mini-monovision group had slightly worse uncorrected visual acuity at 4 m than the emmetropia group (0.16 versus 0.09; P = .002) but better uncorrected acuity at 40 cm (0.25 versus 0.34; P < .001). Binocular uncorrected acuity was not statistically significantly different between groups at 4 m (-0.03 versus -0.01; P = .33) or 66 cm (0.06 versus 0.04; P = .34) but was statistically significant at 40 cm (0.25 versus 0.19; P = .03). CONCLUSIONS: The EDOF toric IOL provided functional distance, intermediate, and near vision. A slight monovision approach appears to improve near visual acuity.
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Emetropia/fisiologia , Implante de Lente Intraocular/métodos , Lentes Intraoculares , Miopia/cirurgia , Refração Ocular/fisiologia , Visão Binocular/fisiologia , Acuidade Visual , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Miopia/fisiopatologia , Estudos Prospectivos , Desenho de PróteseRESUMO
BACKGROUND: Back pain is a leading reason for patients to seek medical attention. Although musculoskeletal causes are common, patients can also present with rarer etiologies. CASE DESCRIPTION: A 50-year-old man presented with 2 months of isolated upper back pain initially suspected to be secondary to overuse muscular strain. During the next 3 months, his pain worsened, and he developed lower extremity dysesthesia and subjective weakness, despite normal neurological examination findings. Nonrevealing laboratory workup included normal muscle enzymes, C-reactive protein, urinalysis, and human leukocyte antigen B27. Magnetic resonance imaging revealed a normal brain but a hypointense C7-T5 epidural mass, prompting a neurosurgical recommendation for laminectomy with evacuation of the suspected hematoma. His symptoms fully and promptly resolved after a 5-day course of prednisone 40 mg. When his symptoms recurred within 2 months, he underwent T4-T5 laminectomy with biopsy of a mass confluent with the dura mater. Initial pathological examination revealed fibrotic tissue of unclear etiology with polyclonal lymphoid infiltrate but no malignant cells, vasculitis, or granulomas. After months of recurrent, steroid-responsive symptoms, he presented to the rheumatology clinic. Repeat spinal magnetic resonance imaging demonstrated progression of epidural thickening with suspected spinal cord compression. Previous biopsy samples were then immunostained for IgG4, revealing focally dense IgG4-positive plasma cells, up to 29 cells per high power field, consistent with spinal IgG4-related hypertrophic pachymeningitis. He began rituximab therapy with a prednisone taper and demonstrated symptomatic and neurologic improvement with successful withdrawal from corticosteroids. CONCLUSIONS: To the best of our knowledge, the present case represents the 12th reported case of spinal IgG4-related hypertrophic pachymeningitis. An early diagnosis and treatment could prevent progression to permanent neurological impairment and functional disability.
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Imunoglobulina G/sangue , Meningite/sangue , Compressão da Medula Espinal/sangue , Medula Espinal , Dor nas Costas/sangue , Dor nas Costas/diagnóstico por imagem , Dor nas Costas/etiologia , Humanos , Hipertrofia/sangue , Hipertrofia/complicações , Hipertrofia/diagnóstico por imagem , Masculino , Meningite/complicações , Meningite/diagnóstico por imagem , Pessoa de Meia-Idade , Medula Espinal/diagnóstico por imagem , Compressão da Medula Espinal/complicações , Compressão da Medula Espinal/diagnóstico por imagemRESUMO
OBJECTIVES: To evaluate the repeatability and reproducibility of the Carl Zeiss Meditec IOLMaster 700, which uses swept-source optical coherence tomography technology, along with its agreement with the IOLMaster 500 and Lenstar LS 900. METHODS: In a clinical practice, complete measurements were taken on one eye of 100 subjects: 51 with cataracts and 49 with clear lenses. Three sets of measurements were taken by 3 operators with three different IOLMaster 700 units, and one operator took 3 measurements with the IOLMaster 500 and the Lenstar. A random-effects model of analysis of variance was used to estimate the repeatability and reproducibility. The 95% limits of agreement (95% LoA) were calculated for all comparisons. RESULTS: Comparing the IOLMaster 700 and IOLMaster 500 in cataract patients, 95% LoA were -0.01 to +0.06 mm for axial length, -0.44 to +0.27 D for corneal power, and -0.18 to +0.17 mm for anterior chamber depth. Comparing the IOLMaster 700 and Lenstar for corneal thickness and lens thickness yielded 95% LoA of -4 to +13 µm and -0.26 to +0.41 mm, respectively. The repeatability and reproducibility limits for the IOLMaster 700 were ±0.014 and ±0.023 mm for axial length; ±0.26 and ±0.27 D for corneal power; ±7 and ±11 µm for corneal thickness; ±0.02 and ±0.02 mm for anterior chamber depth; and ±0.02 and ±0.05 mm for lens thickness, respectively. CONCLUSIONS: There was good agreement between the IOLMaster 700 and comparator instruments and superior or equivalent precision. Some differences were noted, but not considered clinically meaningful.
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Câmara Anterior/diagnóstico por imagem , Biometria/instrumentação , Catarata/diagnóstico , Adulto , Idoso , Idoso de 80 Anos ou mais , Desenho de Equipamento , Feminino , Humanos , Interferometria/instrumentação , Masculino , Pessoa de Meia-Idade , Curva ROC , Reprodutibilidade dos Testes , Tomografia de Coerência Óptica/instrumentação , Adulto JovemRESUMO
PURPOSE: To determine the proportion of eyes with preexisting astigmatism achieving 0.50 diopters (D) or less of residual refractive cylinder 3 months after either implantation of toric intraocular lenses (IOLs) or corneal incisions using the VERION system (Alcon Laboratories, Inc., Fort Worth, TX) measurement module and digital markers for microscope (M) and laser (L). METHODS: Eyes with preexisting astigmatism in the intention-to-treat population were divided into four groups. Eyes in the no laser treatment group underwent toric IOL implantation with the measurement module, vision planner, and digital marker M (n = 102). Eyes in the other three groups underwent implantation of toric (n = 110), monofocal (n = 88), or multifocal (n =100) IOLs using the measurement module, vision planner, and digital marker M, including digital marker L, and LenSx laser (Alcon Laboratories, Inc.). The proportions of eyes achieving 0.50 D or less of relative refractive cylinder and with manifest refraction spherical equivalent (MRSE) deviating 0.50 D or less from the target outcome were evaluated at 3 months. RESULTS: The percentages of eyes achieving 0.50 D or less of relative refractive cylinder in the non-laser-treated, toric, monofocal, and multifocal groups at 3 months were 71.6%, 74.5%, 62.5%, and 71.0%, respectively. The percentages of eyes in these four groups with MRSE accuracies deviating 0.50 D or less from the target at 3 months were 69.6%, 80.0%, 77.3%, and 82.0%, respectively. CONCLUSIONS: The image-guided surgical planning system was effective in accurate correction of preexisting astigmatism in eyes undergoing refractive cataract surgery with IOL implantation, as shown by residual refractive astigmatism and MRSE at 3 months. [J Refract Surg. 2018;34(12):824-831.].
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Astigmatismo/complicações , Catarata/complicações , Implante de Lente Intraocular , Lentes Intraoculares , Facoemulsificação , Cirurgia Assistida por Computador , Idoso , Astigmatismo/fisiopatologia , Catarata/fisiopatologia , Córnea/fisiopatologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Técnicas de Planejamento , Pseudofacia/fisiopatologia , Refração Ocular/fisiologia , Resultado do Tratamento , Acuidade Visual/fisiologiaRESUMO
PURPOSE: To characterize the performance of a multifunctional femtosecond laser system (Lensx) for the creation of laser in situ keratomileusis (LASIK) flaps. SETTING: Two surgical sites in the United States. DESIGN: Prospective case series pilot study. METHODS: Patients with myopia or hyperopia who were eligible for femtosecond laser-initiated LASIK surgery with corrected distance visual acuities (CDVA) correctable to at least 20/25 were enrolled. Central flap thickness accuracy (desired versus achieved) and precision (flap thickness standard deviation) were measured using anterior segment optical coherence tomography. Flap dissection quality, stromal bed quality, and amount of opaque bubble layer (OBL) formation were graded during surgery, and the refractive outcomes were evaluated postoperatively at 1-month and 3-month follow-ups. RESULTS: The study comprised 30 patients (58 eyes). At 3 months postoperatively, the flap thickness accuracy was 1.3 µm ± 2.6 (SD). A total of 78.3% of flaps were lifted with no resistance and 16.7% were lifted with minimal resistance using a blunt instrument. All (100%) stromal beds were determined to have a very smooth surface (grade 5 on a 0 to 5 scale). No OBL was observed in 73.3% of eyes; 26.7% of eyes showed an OBL occurring on less than 24% of the stromal bed surface. At 3 months postoperatively, most eyes (84.5%) had an uncorrected distance visual acuity of 20/20 and 98% had a CDVA of 20/20. The most common ocular adverse event was punctate keratitis (11.7%). CONCLUSION: The multifunctional femtosecond laser system effectively created LASIK flaps that were high quality, accurate, and precise.
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Substância Própria/cirurgia , Hiperopia/cirurgia , Ceratomileuse Assistida por Excimer Laser In Situ/métodos , Lasers de Excimer/uso terapêutico , Miopia/cirurgia , Retalhos Cirúrgicos , Adulto , Substância Própria/diagnóstico por imagem , Feminino , Humanos , Complicações Intraoperatórias , Masculino , Pessoa de Meia-Idade , Projetos Piloto , Estudos Prospectivos , Refração Ocular/fisiologia , Tomografia de Coerência Óptica , Acuidade Visual/fisiologia , Adulto JovemRESUMO
UNLABELLED: We performed a metaanaysis of peer-reviewed studies involving implantation of a multifocal intraocular lens (IOL) in presbyopic patients with cataract or having refractive lens exchange (RLE). Previous reviews have considered the use of multifocal IOLs after cataract surgery but not after RLE, whereas greater insight might be gained from examining the full range of studies. Selected studies were examined to collate outcomes with monocular and binocular uncorrected distance, intermediate, and near visual acuity; spectacle independence; contrast sensitivity; visual symptoms; adverse events; and patient satisfaction. In 8797 eyes, the mean postoperative monocular uncorrected distance visual acuity (UDVA) was 0.05 logMAR ± 0.006 (SD) (Snellen equivalent 20/20(-3)). In 6334 patients, the mean binocular UDVA was 0.04 ± 0.00 logMAR (Snellen equivalent 20/20(-2)), with a mean spectacle independence of 80.1%. Monocular mean UDVA did not differ significantly between those who had a cataract procedure and those who had an RLE procedure. Neural adaptation to multifocality may vary among patients. FINANCIAL DISCLOSURE: Dr. Alió is a clinical research investigator for Hanita Lenses, Carl Zeiss Meditec AG, Topcon Medical Systems, Inc., Oculentis GmbH, and Akkolens International BV. Dr. Dell is a consultant to Bausch & Lomb and Abbott Medical Optics, Inc. Dr. Slade is a consultant to Alcon Surgical, Inc., Carl Zeiss Meditec AG, and Bausch & Lomb. None of the authors has a financial or proprietary interest in any material or method mentioned.
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Implante de Lente Intraocular , Lentes Intraoculares , Facoemulsificação , Pseudofacia/fisiopatologia , Catarata/complicações , Humanos , Presbiopia/complicações , Presbiopia/cirurgia , Desenho de Prótese , Refração Ocular/fisiologia , Reoperação , Resultado do Tratamento , Acuidade Visual/fisiologiaRESUMO
PURPOSE: To evaluate the safety and effectiveness of topography-guided custom ablation treatment (T-CAT) to correct myopia and myopic astigmatism with laser in situ keratomileusis (LASIK). SETTING: Nine clinical sites in the USA. DESIGN: Prospective observational nonrandomized unmasked study. METHODS: The study comprised patients aged 18 to 65 years old with myopia or myopic astigmatism with a manifest refraction spherical equivalent (MRSE) up to -9.0 diopters (D) and astigmatism of 6.0 D or less. Patients with previous refractive surgery or abnormal topography were excluded. Corneal topographies were obtained using the Allegro Topolyzer, and laser treatment was delivered with the Allegretto Wave Eye-Q excimer laser system. Visual outcomes were evaluated postoperatively at 1 day, 1 week, and 1, 3, 6, 9, and 12 months. RESULTS: The clinical trial enrolled 212 patients (249 eyes). The T-CAT procedure significantly reduced the MRSE and cylinder, with stability of outcomes evident from 3 to 12 months after surgery. Compared with the preoperative corrected distance visual acuity (CDVA), the postoperative uncorrected distance visual acuity (UDVA) improved by 1 line or more in 30% of eyes and the postoperative UDVA was at least as good as the preoperative CDVA in 90% of eyes. Most visual symptoms improved after T-CAT. There were no significant treatment-related adverse events or loss of vision. CONCLUSION: The T-CAT procedure performed with the diagnostic device and the refractive excimer laser system safely and effectively achieved predictable refractive outcomes and reduced visual symptoms with stable results through 12 months. FINANCIAL DISCLOSURE: Dr. Stulting is a paid consultant to Alcon Laboratories, Inc., and was a medical monitor for the U.S. Food and Drug Administration (FDA) clinical trial. Dr. Fant is president of Clinical Research Consultants, Inc. (CRC), the clinical and regulatory consulting group that sponsored the FDA clinical trial. Dr. Fant and CRC were supported by Alcon Laboratories, Inc.
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Astigmatismo/cirurgia , Topografia da Córnea , Ceratomileuse Assistida por Excimer Laser In Situ/métodos , Lasers de Excimer/uso terapêutico , Miopia/cirurgia , Cirurgia Assistida por Computador/métodos , Adolescente , Adulto , Idoso , Astigmatismo/fisiopatologia , Sensibilidades de Contraste/fisiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Miopia/fisiopatologia , Estudos Prospectivos , Acuidade Visual/fisiologiaRESUMO
PURPOSE: NewColorIris cosmetic iris implants have a record of high ocular morbidity and are no longer in use. Newer generation of iris implants, BrightOcular, have patented posterior grooves in order to decrease iris touch and facilitate aqueous flow around the implant. However, little is known about their safety despite their implantations in 10 countries. METHODS: Collaborative case series of patients who had bilateral implantation of cosmetic iris implants solely for cosmetic reasons. RESULTS: 12 cases were collected being distributed as Caucasian (10) and Asian (2), women (11) and man (1) and with a mean age of 32â years. Ocular manifestations were present in 11 subjects and included anterior uveitis (10 of 12; 83.3%), glaucoma (7 of 12; 58.3%) and corneal decompensation (6 of 12; 50%). Visual acuity was normal in seven, decreased in five with two having visual recovery following explantation of the implant. Glaucoma could not be controlled medically in two patients. CONCLUSIONS: Cosmetic iris implants carry the risk of ocular damage when implanted in the anterior chamber of normal phakic eyes.
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Perda de Células Endoteliais da Córnea/etiologia , Glaucoma/etiologia , Iris/cirurgia , Irite/etiologia , Complicações Pós-Operatórias , Próteses e Implantes/efeitos adversos , Acuidade Visual , Adulto , Perda de Células Endoteliais da Córnea/diagnóstico , Remoção de Dispositivo , Cor de Olho , Feminino , Glaucoma/diagnóstico , Humanos , Pressão Intraocular , Irite/diagnóstico , Masculino , Falha de Prótese , Adulto JovemRESUMO
PURPOSE: To report 1-year safety and efficacy clinical outcomes of a shape-changing corneal inlay for the treatment of presbyopia. DESIGN: Prospective, nonrandomized, multicenter United States Food and Drug Administration Investigational Device Exemption clinical trial (clinicaltrials.gov identifier, NCT01373580). PARTICIPANTS: Nondominant eyes (N = 373) of emmetropic presbyopic subjects were implanted at 11 sites with the Raindrop Near Vision Inlay (ReVision Optics, Lake Forest, CA); 340 eyes underwent the 1-year follow-up visit. METHODS: The corneal inlay was implanted under a corneal flap at the center of the light-constricted pupil created with a femtosecond laser. MAIN OUTCOME MEASURES: For subjects completing the 1-year follow-up, monocular and binocular uncorrected and corrected visual acuity, refractive stability, contrast sensitivity (CS; photopic and mesopic), symptom and satisfaction questionnaire results, and adverse events. RESULTS: At 1 year in the treated eye, on average, uncorrected near visual acuity (UNVA) improved by 5.1 lines, uncorrected intermediate visual acuity (UIVA) improved by 2.5 lines, and uncorrected distance visual acuity (UDVA) decreased by 1.2 lines. From 3 months through 1 year, 93% of subjects achieved UNVA of 20/25 or better, 97% achieve UIVA of 20/32 or better, and 95% achieved UDVA of 20/40 or better. Binocularly, the mean UDVA exceeded 20/20 from 3 months through 1 year. Contrast sensitivity loss occurred only at the highest spatial frequencies, with no loss binocularly. Absent or mild scores were reported in 96% of subjects for visual symptoms (glare, halos, double vision, and fluctuations in vision), in 99% for ocular symptoms (pain, light sensitivity, and discomfort), and in 95% for dryness. Adverse events were treatable and resolved. Eighteen inlays were replaced, usually soon after implantation because of decentration, but UNVA was little affected in this group thereafter. In the 11 cases requiring inlay explantations, 100% achieved a corrected distance visual acuity of 20/25 or better by 3 months after explant. CONCLUSIONS: The Raindrop Near Vision Inlay provides significant improvement in near and intermediate visual performance, with no significant change in binocular distance vision or CS. Subject satisfaction is improved significantly with minimal ocular or visual symptoms.
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Substância Própria/cirurgia , Emetropia/fisiologia , Hidrogel de Polietilenoglicol-Dimetacrilato , Presbiopia/cirurgia , Próteses e Implantes , Implantação de Prótese , Sensibilidades de Contraste/fisiologia , Cirurgia da Córnea a Laser , Topografia da Córnea , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Satisfação do Paciente/estatística & dados numéricos , Presbiopia/fisiopatologia , Estudos Prospectivos , Desenho de Prótese , Refração Ocular/fisiologia , Retalhos Cirúrgicos , Inquéritos e Questionários , Acuidade Visual/fisiologiaRESUMO
Running shoes are often marketed based on mass. A total of 50 young adult males participated across two separate experiments to determine how well they could perceive the relative masses of five different running shoes using hands versus feet. For the foot portion, subjects were blindly fitted with the shoes and asked to rank their masses individually using visual analogue scales (VAS) and verbal rankings. For the hand portion, two different methods were used, one presenting all shoes simultaneously and the other presenting the shoes individually. Verbal accuracy and VAS scores correlated across subjects for the hand and foot, but accuracy in mass perception by the feet was 30% compared to 92% or 63% by the hand (depending on the method). These results indicate the foot perceives mass poorly compared to the hand, and that consumers' perception of shoe mass may come more from handling shoes versus wearing them.
Assuntos
Pé , Mãos , Sapatos , Percepção de Peso , Adulto , Humanos , Masculino , Corrida , Adulto JovemRESUMO
PURPOSE: To analyze complications of femtosecond lasers used for cataract surgery. SETTING: Department of Ophthalmology Semmelweis University, Budapest, Hungary. DESIGN: Retrospective analysis. METHODS: Intraoperative complications of the first 100 femtosecond laser-assisted (Alcon-Lensx, Inc.) cataract surgeries were collected. Possible complications of femtosecond capsulotomies and their management were also assessed. RESULTS: The complications were as follows: suction break (2%), conjunctival redness or hemorrhage (34%), capsule tags and bridges (20%), anterior tear (4%), miosis (32%), and endothelial damage due to cut within the endothelial layer (3%). There were no cases of capsule blockage or posterior capsule tear. During the learning curve, there was no complication that would require vitrectomy. All complications occurred during the first 100 cases. CONCLUSIONS: Femtosecond laser cataract surgery had a learning curve during the first 100 cases. With cautious surgical technique, the complications can be avoided. The femtosecond laser-assisted method was efficient and safe for cataract surgery.
Assuntos
Extração de Catarata/métodos , Complicações Intraoperatórias , Terapia a Laser/métodos , Extração de Catarata/educação , Humanos , Curva de Aprendizado , Implante de Lente Intraocular , Refração Ocular/fisiologia , Estudos Retrospectivos , Tomografia de Coerência Óptica , Acuidade Visual/fisiologiaRESUMO
PURPOSE: To introduce a new sequential wavefront device with rapid sampling that can be used as an intraoperative, real-time aberrometer/refractometer for immediate diagnosis and management of refractive outcomes during cataract surgery. METHODS: A unique wavefront device uses a rotating prismatic mirror to rapidly shift the incident wavefront emanating from the eye through an aperture for analysis of a sequentially sampled wavefront segment. The sampled segment is then focused onto a quad detector that localizes its angular displacement of the sampled segment's wavefront gradient. Although the device's capability is higher for other applications, the wavefront is herein rapidly sampled at 200 Hz (frames/second), with a 2-mm aperture that moves along a 5-mm outer diameter annulus to capture a real-time analysis of refractive error for intraoperative application (ie, an intraoperative wavefront movie). The prototype wavefront device has been miniaturized into a narrow profile attachment that can be fixed to an operating microscope. In pilot analysis, several eyes undergoing cataract surgery were analyzed to determine both the qualitative and quantitative change in refraction with surgical intervention in an effort to document and improve outcomes intraoperatively. RESULTS: Clinical application of the device was easily implemented without changing or limiting the working distance, magnification, or illumination of the surgeon's ergonomics intraoperatively. The real-time wavefront outcome was visualized overlaying a live eye image, presenting the refractive error both qualitatively and quantitatively. Qualitative representation of spherical refractive error was seen as a circle, cylinder as a thin ellipse, and emmetropia as a dot. Localization of lower-order aberrations with a practical sample rate of 200 frames/ second enables a real-time visualization of qualitative refractive data coaxially aligned with the eye image and quantitatively as sphere, cylinder, and axis at the bottom of the screen. Practical evaluation of residual cylinder prior to and during limbal relaxing incision placement, rotational accuracy during toric intraocular lens alignment, and refractive effect of subtle surgical maneuvers were all achieved with this device. CONCLUSION: Real-time, intraoperative refraction and visualization is possible with a new sequential wavefront device attached to the operating microscope. The precision and accuracy of intraoperative documentation and refinement of outcomes is likely to be enhanced, making this an important future tool for optimizing cataract surgery outcomes.