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1.
Ophthalmology ; 123(4): 723-8, 2016 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-26804760

RESUMO

PURPOSE: To identify safety and effectiveness outcomes of office-based cataract surgery. Each year, approximately 3.7 million cataract surgeries in the United States are performed in Ambulatory Surgery Center (ASC) and Hospital Outpatient Department (HOPD) locations. Medicare in July 2015 published a solicitation for expert opinion on reimbursing office-based cataract surgery. DESIGN: Large-scale, retrospective, consecutive case series of cataract surgeries performed in Minor Procedure Rooms (MPRs) of a large US integrated healthcare center. PARTICIPANTS: More than 13 500 patients undergoing elective office-based cataract surgery. METHODS: Phacoemulsification cataract surgery performed in MPRs of Kaiser Permanente Colorado from 2011 to 2014. MAIN OUTCOME MEASURES: Postoperative visual acuity and intraoperative and postoperative adverse events (AEs). RESULTS: Office-based cataract surgery was completed in 21 501 eyes (13 507 patients, age 72.6±9.6 years). Phacoemulsification was performed in 99.9% of cases, and manual extracapsular extraction was performed in 0.1% of cases. Systemic comorbidities included hypertension (53.5%), diabetes (22.3%), and chronic obstructive pulmonary disease (9.4%). Postoperative mean best-corrected visual acuity measured 0.14±0.26 logarithm of the minimum angle of resolution units. Intraoperative ocular AEs included 119 (0.55%) cases of capsular tear and 73 (0.34%) cases of vitreous loss. Postoperative AEs included iritis (n = 330, 1.53%), corneal edema (n = 110, 0.53%), and retinal tear or detachment (n = 30, 0.14%). No endophthalmitis was reported. Second surgeries were performed in 0.70% of treated eyes within 6 months. There were no life- or vision-threatening intraoperative or perioperative AEs. CONCLUSIONS: This is the largest US study to investigate the safety and effectiveness of office-based cataract surgery performed in MPRs. Office-based efficacy outcomes were consistently excellent, with a safety profile expected of minimally invasive cataract procedures performed in ASCs and HOPDs.


Assuntos
Procedimentos Cirúrgicos Ambulatórios/normas , Complicações Intraoperatórias , Implante de Lente Intraocular , Facoemulsificação/normas , Complicações Pós-Operatórias , Acuidade Visual/fisiologia , Idoso , Idoso de 80 Anos ou mais , Instituições de Assistência Ambulatorial/normas , Procedimentos Cirúrgicos Ambulatórios/efeitos adversos , Bases de Dados Factuais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Avaliação de Processos e Resultados em Cuidados de Saúde , Facoemulsificação/efeitos adversos , Estudos Retrospectivos , Resultado do Tratamento , Estados Unidos
2.
Ophthalmology ; 123(10): 2103-12, 2016 10.
Artigo em Inglês | MEDLINE | ID: mdl-27506486

RESUMO

PURPOSE: We evaluated 2-year safety and efficacy of supraciliary microstenting (CyPass Micro-Stent; Transcend Medical, Inc., Menlo Park, CA) for treating mild-to-moderate primary open-angle glaucoma (POAG) in patients undergoing cataract surgery. DESIGN: Multicenter (24 US sites), interventional randomized clinical trial (RCT) (ClinicalTrials.gov identifier, NCT01085357). PARTICIPANTS: Subjects were enrolled beginning July 2011, with study completion in March 2015. Subjects had POAG with mean diurnal unmedicated intraocular pressure (IOP) 21-33 mmHg and were undergoing phacoemulsification cataract surgery. METHODS: After completing cataract surgery, subjects were intraoperatively randomized to phacoemulsification only (control) or supraciliary microstenting with phacoemulsification (microstent) groups (1:3 ratio). Microstent implantation via an ab interno approach to the supraciliary space allowed concomitant cataract and glaucoma surgery. MAIN OUTCOME MEASURES: Outcome measures included percentage of subjects achieving ≥20% unmedicated diurnal IOP lowering versus baseline, mean IOP change and glaucoma medication use, and ocular adverse event (AE) incidence through 24 months. RESULTS: Of 505 subjects, 131 were randomized to the control group and 374 were randomized to the microstent group. Baseline mean IOPs in the control and microstent groups were similar: 24.5±3.0 and 24.4±2.8 mmHg, respectively (P > 0.05); mean medications were 1.3±1.0 and 1.4±0.9, respectively (P > 0.05). There was early and sustained IOP reduction, with 60% of controls versus 77% of microstent subjects achieving ≥20% unmedicated IOP lowering versus baseline at 24 months (P = 0.001; per-protocol analysis). Mean IOP reduction was ↓7.4 mmHg for the microstent group versus ↓5.4 mmHg in controls (P < 0.001), with 85% of microstent subjects not requiring IOP medications at 24 months. Mean 24-month medication use was 67% lower in microstent subjects (P < 0.001); 59% of control versus 85% of microstent subjects were medication free. Mean medication use in controls decreased from 1.3±1.0 drugs at baseline to 0.7±0.9 and 0.6±0.8 drugs at 12 and 24 months, respectively, and in the microstent group from 1.4±0.9 to 0.2±0.6 drugs at both 12 and 24 months (P < 0.001 for reductions in both groups at both follow-ups vs. baseline). No vision-threatening microstent-related AEs occurred. Visual acuity was high in both groups through 24 months; >98% of all subjects achieved 20/40 best-corrected visual acuity or better. CONCLUSIONS: This RCT demonstrated safe and sustained 2-year reduction in IOP and glaucoma medication use after microinterventional surgical treatment for mild-to-moderate POAG.


Assuntos
Catarata/complicações , Corpo Ciliar/cirurgia , Cirurgia Filtrante/métodos , Glaucoma de Ângulo Aberto/cirurgia , Pressão Intraocular/fisiologia , Facoemulsificação/métodos , Stents , Idoso , Idoso de 80 Anos ou mais , Feminino , Seguimentos , Glaucoma de Ângulo Aberto/complicações , Glaucoma de Ângulo Aberto/fisiopatologia , Gonioscopia , Humanos , Masculino , Pessoa de Meia-Idade , Miniaturização , Período Pós-Operatório , Desenho de Prótese , Estudos Retrospectivos , Fatores de Tempo , Tonometria Ocular , Resultado do Tratamento , Acuidade Visual
3.
Curr Opin Ophthalmol ; 26(1): 28-33, 2015 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-25390860

RESUMO

PURPOSE OF REVIEW: The objective of this review is to evaluate the result of cataract surgery in patients continuing antiplatelet and/or anticoagulant treatment. RECENT FINDINGS: The number of elderly patients using anticoagulant and antiplatelet treatment in prevention of venous thromboembolism has significantly increased in recent years. It was believed for many years that those patients might be at higher risk for complications during ocular surgery. Thus, different strategies were proposed to prevent these complications, including discontinuation of anticoagulants, dose reduction, or low-molecular-weight heparin replacement. We performed a PubMed search over a period of 7 years (2007-2013) about possible intraoperative and postoperative complications in patients receiving anticoagulant and/or antiplatelet therapy at the time of cataract surgery. No significant increase in intraoperative or postoperative complications has been identified. SUMMARY: Phacoemulsification of uncomplicated cataracts with intraocular lens implantation can be performed safely in high-risk patients, taking both anticoagulants and antiplatelet drugs when topical anesthesia is administered and cataract surgery is performed through a clear corneal incision by a skilled surgeon.


Assuntos
Anticoagulantes/administração & dosagem , Implante de Lente Intraocular , Facoemulsificação , Inibidores da Agregação Plaquetária/administração & dosagem , Anticoagulantes/efeitos adversos , Humanos , Complicações Intraoperatórias , Inibidores da Agregação Plaquetária/efeitos adversos , Complicações Pós-Operatórias , Tromboembolia Venosa/prevenção & controle
4.
Artigo em Inglês | MEDLINE | ID: mdl-38875184

RESUMO

PURPOSE: Evaluate effectiveness and safety of a crosslinked hyaluronate (HA) canalicular filler (Lacrifill Canalicular Gel) compared to a commercially available hydrogel canalicular plug (Form Fit). SETTING: 5 sites in United States. DESIGN: Prospective, multicenter, controlled, double-masked, randomized 2:1 (filler:plug). METHODS: Adults (≥22 years) with Schirmer test (with anesthesia) ≤10 mm/5 minutes, presence of corneal staining, ocular surface disease index (OSDI) of ≥23 with ≤3 responses of "not applicable," patent lacrimal drainage system, and bilateral best-corrected distance visual acuity of 20/40 or better. Filler or plugs were instilled bilaterally in the inferior canaliculi. Primary effectiveness endpoint was non-inferiority of the mean within subject change from baseline to Month 3 in Schirmer score for patients receiving filler compared to plugs. The key secondary effectiveness endpoint was non-inferiority of the proportion of patients with filler achieving improvement from baseline to Month 3 in OSDI by a minimal clinically important difference (MCID). Additional endpoints included the mean change from baseline to 3 and 6 months in tear meniscus height, OSDI, corneal staining, tear break-up time, and safety. RESULTS: 157 patients were randomized; 99 patients with crosslinked HA filler and 52 patients with hydrogel plugs completed the study. Filler was non-inferior to plugs in the mean Schirmer score change from baseline and in the proportion of patients achieving a clinically important improvement in OSDI. CONCLUSIONS: Crosslinked HA filler is a safe, well-tolerated, and effective method to treat dry eye. Clinically and statistically significant improvements in signs and symptoms of dry eye were sustained through 6 months.

5.
Am J Orthod Dentofacial Orthop ; 143(5): 738-44, 2013 May.
Artigo em Inglês | MEDLINE | ID: mdl-23631976

RESUMO

INTRODUCTION: Although natural head position has proven to be reliable in the sagittal plane, with an increasing interest in 3-dimensional craniofacial analysis, a determination of its reproducibility in the coronal and axial planes is essential. This study was designed to evaluate the reproducibility of natural head position over time in the sagittal, coronal, and axial planes of space with 3-dimensional imaging. METHODS: Three-dimensional photographs were taken of 28 adult volunteers (ages, 18-40 years) in natural head position at 5 times: baseline, 4 hours, 8 hours, 24 hours, and 1 week. Using the true vertical and horizontal laser lines projected in an iCAT cone-beam computed tomography machine (Imaging Sciences International, Hatfield, Pa) for orientation, we recorded references for natural head position on the patient's face with semipermanent markers. By using a 3-dimensional camera system, photographs were taken at each time point to capture the orientation of the reference points. By superimposing each of the 5 photographs on stable anatomic surfaces, changes in the position of the markers were recorded and assessed for parallelism by using 3dMDvultus (3dMD, Atlanta, Ga) and software (Dolphin Imaging & Management Solutions, Chatsworth, Calif). RESULTS: No statistically significant differences were observed between the 5 time points in any of the 3 planes of space. However, a statistically significant difference was observed between the mean angular deviations of 3 reference planes, with a hierarchy of natural head position reproducibility established as coronal > axial > sagittal. CONCLUSIONS: Within the parameters of this study, natural head position was found to be reproducible in the sagittal, coronal, and axial planes of space. The coronal plane had the least variation over time, followed by the axial and sagittal planes.


Assuntos
Cefalometria , Tomografia Computadorizada de Feixe Cônico , Cabeça/diagnóstico por imagem , Imageamento Tridimensional , Postura , Adolescente , Adulto , Cefalometria/instrumentação , Humanos , Estudos Longitudinais , Reprodutibilidade dos Testes , Adulto Jovem
6.
J Cataract Refract Surg ; 49(8): 804-811, 2023 08 01.
Artigo em Inglês | MEDLINE | ID: mdl-37079390

RESUMO

PURPOSE: To evaluate the safety and effectiveness of a new cohesive ophthalmic viscosurgical device (OVD) (StableVisc) compared with a marketed cohesive OVD (ProVisc) in patients undergoing cataract surgery. SETTING: 22 sites in the United States. DESIGN: Prospective multicenter controlled double-masked and randomized 1:1 (StableVisc:ProVisc; stratified by site, age group, and cataract severity). METHODS: Adults (≥45 years) with age-related noncomplicated cataract considered amenable to treatment with standard phacoemulsification cataract extraction and intraocular lens implantation were included. Patients were randomized to receive either StableVisc or ProVisc during standard cataract surgery. Postoperative visits occurred at 6 hours, 24 hours, 7 days, 1 month, and 3 months. The primary effectiveness outcome was the change in endothelial cell density (ECD) from baseline to 3 months. The primary safety endpoint was the proportion of patients who experienced at least 1 intraocular pressure (IOP) measurement ≥30 mm Hg at any follow-up visit. Noninferiority between the devices was tested. Inflammation and adverse events were evaluated. RESULTS: 390 patients were randomized; 187 patients with StableVisc and 193 patients with ProVisc completed the study. StableVisc was noninferior to ProVisc in mean ECD loss from baseline to 3 months (17.5% and 16.9%, respectively). StableVisc was noninferior to ProVisc in the proportion of patients with postoperative IOP ≥30 mm Hg at any follow-up visit (5.2% and 8.2%, respectively). CONCLUSIONS: The StableVisc cohesive OVD, which provides both mechanical and chemical protection, was safe and effective when used in cataract surgery and provides surgeons with a new cohesive OVD.


Assuntos
Catarata , Facoemulsificação , Adulto , Humanos , Implante de Lente Intraocular , Estudos Prospectivos , Ácido Hialurônico/uso terapêutico , Olho , Catarata/induzido quimicamente , Pressão Intraocular
7.
Ophthalmology ; 124(1): e12, 2017 01.
Artigo em Inglês | MEDLINE | ID: mdl-27993273
8.
BMC Med Educ ; 12: 1, 2012 Jan 12.
Artigo em Inglês | MEDLINE | ID: mdl-22240206

RESUMO

BACKGROUND: Mobile technology is increasingly being used by clinicians to access up-to-date information for patient care. These offer learning opportunities in the clinical setting for medical students but the underlying pedagogic theories are not clear. A conceptual framework is needed to understand these further. Our initial questions were how the medical students used the technology, how it enabled them to learn and what theoretical underpinning supported the learning. METHODS: 387 medical students were provided with a personal digital assistant (PDA) loaded with medical resources for the duration of their clinical studies. Outcomes were assessed by a mixed-methods triangulation approach using qualitative and quantitative analysis of surveys, focus groups and usage tracking data. RESULTS: Learning occurred in context with timely access to key facts and through consolidation of knowledge via repetition. The PDA was an important addition to the learning ecology rather than a replacement. Contextual factors impacted on use both positively and negatively. Barriers included concerns of interrupting the clinical interaction and of negative responses from teachers and patients. Students preferred a future involving smartphone platforms. CONCLUSIONS: This is the first study to describe the learning ecology and pedagogic basis behind the use of mobile learning technologies in a large cohort of undergraduate medical students in the clinical environment. We have developed a model for mobile learning in the clinical setting that shows how different theories contribute to its use taking into account positive and negative contextual factors.The lessons from this study are transferable internationally, to other health care professions and to the development of similar initiatives with newer technology such as smartphones or tablet computers.


Assuntos
Computadores de Mão/estatística & dados numéricos , Educação de Graduação em Medicina/métodos , Avaliação Educacional , Adulto , Competência Clínica , Computadores de Mão/economia , Análise Custo-Benefício , Feminino , Grupos Focais , Humanos , Masculino , Computação em Informática Médica/normas , Projetos Piloto , Estudantes de Medicina/estatística & dados numéricos , Inquéritos e Questionários , Reino Unido
9.
Clin Ophthalmol ; 16: 1541-1553, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35645557

RESUMO

Purpose: To evaluate the safety and effectiveness of Collamer posterior chamber phakic refractive lenses with a central port design (EVO and EVO+ Sphere and Toric Visian ICLs) for correction of moderate-to-high myopia with or without astigmatism. Patients and Methods: Six-month results of a multicenter clinical trial performed under United States FDA Investigational Device Exemption. Subjects 21 through 45 years of age with myopia ranging from -3.00 D to -20.00 D and astigmatism up to 4.00 D underwent implantation of EVO or EVO+ Sphere or Toric Visian ICLs. Uncorrected (UDVA) and corrected (CDVA) distance visual acuities, manifest refraction, intraocular pressure (IOP), endothelial cell density, and adverse events were evaluated over 6 months. Results: This clinical trial enrolled 629 eyes of 327 subjects with mean age 35.6 ± 5.09 years. Mean preoperative spherical equivalent (SE) measured -7.62 ± 2.75 D (range: -3.00 to -15.62 D). At 6 months, mean SE was -0.079 ± 0.33 D, with 90.5% within ± 0.50 D of target and 98.9% within ±1.00 D of target. Mean postoperative UDVA and CDVA were -0.059 ± 0.10 logMAR and -0.13 ± 0.08 logMAR, respectively. 52.3% of eyes gained lines of CDVA. Efficacy and safety indices were 1.06 and 1.24, respectively. No eye experienced pupillary block, required peripheral iridotomy or iridectomy, developed anterior subcapsular cataract or had elevated IOP due to angle narrowing or pigment dispersion. Mean endothelial cell density declined by 2.3%. Conclusion: EVO ICL lenses demonstrated accuracy of refractive correction and achievement of high levels of UDVA. This clinical trial confirmed that the central port design of EVO and EVO+ Sphere and Toric Visian ICL lenses functions effectively to allow physiologic flow of aqueous humor, thus eliminating the requirement for preoperative peripheral iridotomies. The results of this clinical trial resulted in FDA approval on March 25, 2022.

10.
Clin Ophthalmol ; 16: 3981-3991, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36510599

RESUMO

Purpose: To evaluate the safety and effectiveness of collamer posterior chamber phakic refractive lenses with a central port design (EVO and EVO+ Sphere and Toric implantable collamer lenses [ICLs]) for correction of moderate myopia with or without astigmatism. Patients and Methods: Six-month results of a multicenter clinical trial were performed under United States FDA Investigational Device Exemption. Subjects 21 through 45 years of age with manifest refraction spherical equivalent ranging from -3.00 D to -6.00 D and astigmatism up to 4.00 D underwent implantation of EVO or EVO+ Sphere or Toric ICLs. Uncorrected (UDVA) and corrected (CDVA) distance visual acuities, manifest refraction, intraocular pressure (IOP), endothelial cell density, and adverse events were evaluated over 6 months. Results: This report includes a retrospective review of 200 eyes of 114 subjects with mean age 35.1 ± 5.1 years that completed the 6-month visit. Mean preoperative spherical equivalent (SE) measured -4.61 ± 0.87 D (range: -3.00 to -6.00 D). At 6 months, mean SE was -0.085 ± 0.26 D, with 91.5% within ± 0.50 D of target and 100.0% within ±1.00 D of target. Mean postoperative UDVA and CDVA were -0.065 ± 0.08 logMAR and -0.14 ± 0.07 logMAR, respectively. About 98.0% of eyes maintained or gained lines of CDVA, and no eye lost more than 1 line CDVA. Efficacy and safety indices were 1.03 and 1.21, respectively. No eye experienced pupillary block, required preoperative or postoperative peripheral iridotomy or iridectomy, developed anterior subcapsular cataract or had elevated IOP due to angle narrowing or pigment dispersion. Mean endothelial cell density declined by 2.2%. Conclusion: EVO ICL lenses demonstrated accuracy, predictability and stability of refractive correction with achievement of high levels of UDVA and an excellent safety profile for patients with moderate myopia with or without astigmatism.

11.
Clin Ophthalmol ; 16: 3763-3774, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36411875

RESUMO

Purpose: To assess the refractive outcomes, intraocular centration and rotational stability of the enVista toric intraocular lens (IOL). Patients and Methods: This study was a prospective, multi-centre, double-masked, partially randomized and partially controlled clinical trial. A total of 191 participants were implanted with toric IOL (1.25, 2.00, or 2.75D) or non-toric IOL (control). The lowest range of corneal astigmatic eyes were randomized to 1.25D toric or control. Higher astigmatic powers were allocated to the treatment arm. Subjects were assessed immediately postoperatively, 1-2 (V1), 7-14 (V2), 30-60 (V3) and 120-180 (V4) days postoperatively. Unaided (UDVA) and distance corrected visual acuity (CDVA), manifest refraction and corneal curvature were assessed. Vector analysis was used to calculate surgically induced refractive correction (SIRC), correction ratio (CR), error magnitude (EM) and error vector (EV). Slit-lamp photography was used to measure centration and rotational stability. Results: UDVA was better in the low toric IOL group in comparison with the control group at V4 (p<0.001). There was an undercorrection in the control group, whereas the average CR for all toric subjects was 1.00 ± 0.32: V2, 0.98 ± 0.34: V3 and 0.98 ± 0.35: V4. The absolute IOL rotational stability in comparison to the position of the IOL at V1 was 1.35° ± 0.97°: V2, 1.35° ± 1.07°: V3 and 1.38° ± 1.25°: V4. Decentration was generally inferior (V1: 0.04 ± 0.22mm, V2: 0.05± 0.20mm, V3: 0.08 ± 0.22mm, V4: 0.04 ± 0.21mm) and nasal (V1: 0.19 ± 0.23mm, V2: 0.20 ± 0.20mm, V3: 0.20 ± 0.21mm, V4: 0.17 ± 0.22mm). Conclusion: Participants with low levels of corneal astigmatism achieved superior vision and refractive outcomes in the low toric group over the control. Moderate and high levels of astigmatism achieved excellent refractive outcomes. The toric IOL demonstrated high levels of both rotational and centrational stability.

12.
J Cataract Refract Surg ; 48(9): 1050-1056, 2022 09 01.
Artigo em Inglês | MEDLINE | ID: mdl-35137696

RESUMO

PURPOSE: To evaluate the safety and effectiveness of a new dispersive ophthalmic viscosurgical device (OVD) (ClearVisc) compared with an approved dispersive OVD (Viscoat) when used in cataract surgery. SETTING: 16 clinics in the United States. DESIGN: Prospective multicenter controlled randomized 1:1 (ClearVisc:Viscoat; stratified by site, age group, and cataract severity). Patients and examiners masked. METHODS: Patients aged 45 years or older with age-related noncomplicated cataract considered amenable to treatment with standard phacoemulsification cataract extraction and intraocular lens (IOL) implantation were included. Patients were randomized to receive either ClearVisc or Viscoat using standard techniques. 5 postoperative visits occurred at 6 hours, 24 hours, 7 days, 1 month, and 3 months. The primary effectiveness outcome was the change in endothelial cell density (ECD) from baseline to 3 months. The primary safety end point was the proportion of patients who experienced at least 1 intraocular pressure (IOP) measurement ≥30 mm Hg at any follow-up visit. Noninferiority was tested. Inflammation and adverse events were evaluated. RESULTS: 372 patients were randomized: 184 patients in the ClearVisc group and 188 patients in the Viscoat group. ClearVisc was noninferior to Viscoat in mean percentage of ECD loss from baseline to 3 months (8.4% and 6.8%, respectively). ClearVisc was significantly noninferior to Viscoat in the proportion of patients with postoperative IOP ≥30 mm Hg at any follow-up visit (17.4% and 20.3%, respectively, P = .0002). CONCLUSIONS: ClearVisc dispersive OVD provides surgeons with a new option in the continuum of approved dispersive OVDs with beneficial properties as a surgical aid in cataract extraction and IOL implantation.


Assuntos
Catarata , Facoemulsificação , Sulfatos de Condroitina , Combinação de Medicamentos , Endotélio Corneano , Humanos , Ácido Hialurônico , Pressão Intraocular , Implante de Lente Intraocular , Estudos Prospectivos
13.
Eye Vis (Lond) ; 8(1): 41, 2021 Dec 01.
Artigo em Inglês | MEDLINE | ID: mdl-34847968

RESUMO

BACKGROUND: To evaluate the accuracy and safety of micro radial and arcuate keratotomy incisions constructed by a femtosecond laser system with a curved contact patient interface in porcine eyes. METHODS: Partial thickness micro radial and arcuate keratotomy incisions were constructed in porcine eyes with a femtosecond laser system and evaluated for precision of depth, quality, and consistency. Optical coherence tomography was used to determine the accuracy and precision of incision depth. Corneal endothelial safety was assessed by a fluorescent live/dead cell viability assay to demonstrate laser-induced endothelial cell loss. Quality was evaluated by ease of opening and examination of interfaces. RESULTS: In two micro radial incision groups, intended incision depths of 50% and 80% resulted in mean achieved depths of 50.01% and 77.69%, respectively. In three arcuate incision groups, intended incision depths of 80%, 600 µm or 100 µm residual uncut bed thickness resulted in mean achieved depths of 80.16%, 603.03 µm and residual bed of 115 µm, respectively. No loss of endothelial cell density occurred when the residual corneal bed was maintained at a minimum of 85-116 µm. The incisions were easy to open, and interfaces were smooth. CONCLUSIONS: A femtosecond laser system with curved contact interface created precise and reproducible micro radial and arcuate keratotomy incisions. Accuracy and precision of the incision depth and preservation of endothelial cell density demonstrated the effectiveness and safety of the system.

14.
Ann Otol Rhinol Laryngol ; 119(6): 402-5, 2010 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-20583739

RESUMO

Vestibular schwannomas are benign neoplasms that arise from Schwann cells of the eighth cranial nerve. Most manifest clinically with tinnitus, unilateral sensorineural hearing loss, and dysequilibrium secondary to compression of the vestibulocochlear nerve; major adverse events such as intratumoral hemorrhage causing acute neurologic deterioration are rare. We report the case of a 69-year-old man with a large vestibular schwannoma who required anticoagulation for several medical comorbidities. The patient began having progressively worsening neurologic symptoms, including facial nerve paralysis and dysequilibrium, which confined him to a wheelchair. After presentation, the patient was admitted to the hospital. Several days after alteration of his anticoagulation therapy in preparation for surgery, he developed intracranial hemorrhage. Attempts were made to stabilize the patient, including posterior fossa craniectomy and evacuation of hematoma; however, the intracranial hemorrhage ultimately resulted in a fatal outcome. During this procedure, a biopsy specimen was obtained, showing benign vestibular schwannoma. The literature for intratumoral hemorrhage into vestibular schwannoma and the pathologic findings in our case are reviewed.


Assuntos
Hemorragias Intracranianas/etiologia , Neuroma Acústico/complicações , Idoso , Anticoagulantes/uso terapêutico , Comorbidade , Progressão da Doença , Evolução Fatal , Próteses Valvulares Cardíacas , Humanos , Imuno-Histoquímica , Imageamento por Ressonância Magnética , Masculino , Neuroma Acústico/epidemiologia , Neuroma Acústico/metabolismo , Estudos Retrospectivos , Varfarina/uso terapêutico
15.
Clin Ophthalmol ; 14: 2717-2730, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32982164

RESUMO

PURPOSE: To evaluate the performance and safety of the Extended Depth of Focus Implantable Collamer® Lens (EDOF ICL) for improvement of uncorrected near, intermediate and distance visual acuity in phakic subjects with myopia and presbyopia. DESIGN: Prospective multicenter study. METHODS: Presbyopic subjects who required an EDOF ICL in the range of -0.50 D to -18.00 D, exhibited ≤ 0.75 D refractive astigmatism and required from +1.00 to +2.50 D reading add were implanted bilaterally. Assessments at 6 months included uncorrected near, intermediate and distance visual acuities, defocus curves, contrast sensitivity, responses to the National Eye Institute Refractive Error Quality of Life Questionnaire and a Task Assessment Questionnaire. RESULTS: A total of 34 subjects completed the study. Investigators targeted emmetropia in all eyes. Mean binocular uncorrected near, intermediate and distance visual acuities measured logMAR -0.01 ± 0.05 (20/20), -0.02 ± 0.08 (20/19) and 0.07 ± 0.10 (20/23), respectively. Mean monocular uncorrected near, intermediate and distance visual acuities measured logMAR 0.068 ± 0.09 (20/23), 0.062 ± 0.10 (20/23) and 0.16 ± 0.12 (20/29). There were no clinically or statistically significant differences in contrast sensitivity between baseline and 6 months under any testing conditions. Subjects reported significant improvements in measures of vision-related quality of life and ability to perform tasks at all distances without glasses or contact lenses. Overall, satisfaction with the EDOF ICL was high: postoperatively, 91.2% of subjects were satisfied with their vision. CONCLUSION: This multicenter, prospective clinical investigation demonstrated the ability of the EDOF ICL to correct myopia and presbyopia, resulting in improvement of uncorrected near, intermediate and distance visual acuity without compromising the quality of vision. The EDOF ICL allowed subjects to perform tasks of daily living without glasses or contact lenses. Subjects reported significant improvements in quality of life with high levels of spectacle independence and satisfaction.

16.
J Refract Surg ; 25(1): 12-20, 2009 01.
Artigo em Inglês | MEDLINE | ID: mdl-19244948

RESUMO

PURPOSE: To determine the feasibility of selectively targeting zero total postoperative spherical aberration by selecting the best fit aspheric intraocular lens (IOL) based on preoperative topographically derived corneal spherical aberration. METHODS: Candidates for cataract surgery were offered selection of aspheric IOLs based on corneal spherical aberration. The target postoperative total wavefront spherical aberration Z4,0 was set at zero. Corneal topographic spherical aberration Z4,0 was measured at the 6-mm optical zone, and one of three aspheric IOLs was chosen so the arithmetic sum of the corneal spherical aberration and pseudophakic spherical aberration came closest to zero. Postoperatively, total ocular wavefront was measured and statistical analysis performed to ascertain the accuracy of customized aspheric IOL selection. RESULTS: Thirty eyes of 18 patients were available for analysis. The SofPort Advanced Optics (Bausch & Lomb) lens was implanted in 1 eye, the AcrySof IQ (Alcon Laboratories Inc) in 11 eyes, and the Tecnis Z9000 or Z9002 (Advanced Medical Optics [AMO]) in 18 eyes. Total postoperative ocular spherical aberration for the entire population measured -0.013+/-0.072 microm (SofPort: +0.025 microm; AcrySof IQ: +0.010+/-0.053 microm; and Tecnis: -0.015+/-0.052 microm [P=.22]). For the entire population, mean absolute predictive error measured 0.058+/-0.056 microm (SofPort: 0.040 microm; AcrySof IQ: 0.052+/-0.040 microm; and Tecnis: 0.063+/-0.066 microm [P=.631). CONCLUSIONS: Customized selection of aspheric IOLs based on corneal wavefront is feasible and produces favorable results compared with studies of unselected patient populations implanted with aspheric IOLs.


Assuntos
Topografia da Córnea , Implante de Lente Intraocular , Lentes Intraoculares , Facoemulsificação , Complicações Pós-Operatórias , Erros de Refração/prevenção & controle , Idoso , Idoso de 80 Anos ou mais , Estudos de Viabilidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Desenho de Prótese , Erros de Refração/etiologia
18.
Gerodontology ; 26(1): 11-8, 2009 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-19278520

RESUMO

OBJECTIVE: To investigate how dental implants impact on the oral health quality of life of people with Parkinson's disease (PD). BACKGROUND: PD is a progressive neurological disorder that can result in a number of oral health care challenges, including denture difficulties. Lack of evidence related to use of implants in PD prompted this study to investigate their use in this group of people. MATERIALS AND METHODS: Nine people with PD were provided with either fixed or removable prostheses using Astra-Tech implants. Participants completed the socio-dental questionnaire, 'The Dental Impact on Daily Living Assessment' (DIDL) prior to implant surgery, and at 3 and 12 months after provision of the final prosthesis. DIDL comprises two components - the Oral Health Quality of Life Inventory (OH-QoL) and the Self-Reported Assessment of Oral Health and Functional Status (SROH). RESULTS: Nine people (with an age range of 54-77 years) had implants placed. The implant success rate was 85 and 81% in the maxilla and mandible, respectively. The OH-QoL and SROH results (analysed using the one-way analysis of variance and pairwise multiple comparisons) demonstrated a significant improvement in the domains of eating and satisfaction with the prosthesis after 3 months, which was maintained at the twelve month review. The OH-QoL indicated a gradual improvement in oral well-being over the 12-month period. CONCLUSION: The oral health quality of life of people with PD was improved by the use of dental implants, indicating this as a viable treatment option.


Assuntos
Implantes Dentários , Prótese Dentária Fixada por Implante , Saúde Bucal , Doença de Parkinson/psicologia , Qualidade de Vida , Atividades Cotidianas , Idoso , Prótese Total , Revestimento de Dentadura , Prótese Parcial Fixa , Ingestão de Alimentos/fisiologia , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Satisfação do Paciente , Autoimagem , Ajustamento Social
19.
J Cataract Refract Surg ; 45(12): 1762-1769, 2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-31856987

RESUMO

PURPOSE: To evaluate the outcomes of femtosecond laser-assisted arcuate keratotomy combined with cataract surgery in eyes with low-to-moderate corneal astigmatism. SETTING: Eyes of York Private Practice Ophthalmology Clinic, York, Pennsylvania, USA. DESIGN: Retrospective case series. METHODS: This retrospective analysis included case records of patients with preexisting corneal astigmatism ranging from 0.5 to 2.0 diopter (D). Study parameters included corneal astigmatism, refractive astigmatism, and uncorrected (UDVA) and corrected (CDVA) distance visual acuities. The results, which were analyzed at 3 months postoperatively, included frequency distribution histograms, vector analysis, and single-angle polar plots. RESULTS: The study comprised case records of 189 eyes of 143 patients (56 men and 87 women). The postoperative refractive astigmatism was reduced significantly compared with preoperative corneal astigmatism to 0.14 D ± 0.23 (SD) from 0.92 ± 0.34 D (P < .001). One hundred eighty-one eyes (95.8%) demonstrated postoperative refractive astigmatism of 0.5 D or less. The mean surgically induced change along the preoperative steep axis was -0.59 ± 0.56 D, and the change along the orthogonal axis was 0.01 ± 0.35 D. Postoperatively, 171 eyes (90.5%) had astigmatism angle of error of 15 degrees or less. The postoperative mean UDVA and CDVA were 0.09 ± 0.16 logarithm of the minimum angle of resolution (logMAR) and 0.02 ± 0.05 logMAR, respectively. One hundred seventy eyes (90%) had a postoperative UDVA of 20/30 or better. The results demonstrated stability at 12 months postoperatively. No intraoperative or postoperative arcuate keratotomy-related events were observed. CONCLUSION: The results suggest that femtosecond laser-assisted arcuate keratotomy represents a safe and effective method for astigmatism correction at the time of cataract surgery with demonstrated stability of correction for at least 1 year postoperatively.


Assuntos
Astigmatismo/cirurgia , Extração de Catarata/métodos , Córnea/cirurgia , Ceratoplastia Penetrante/métodos , Terapia a Laser/métodos , Implante de Lente Intraocular/métodos , Refração Ocular/fisiologia , Adulto , Idoso , Astigmatismo/complicações , Astigmatismo/diagnóstico , Córnea/patologia , Topografia da Córnea , Feminino , Seguimentos , Humanos , Período Intraoperatório , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Acuidade Visual , Adulto Jovem
20.
J Cataract Refract Surg ; 45(8): 1177-1182, 2019 08.
Artigo em Inglês | MEDLINE | ID: mdl-31272777

RESUMO

PURPOSE: To compare the capsulotomy rim strength with capsular marks (CMs) to the rim strength without CMs in porcine eyes, and to demonstrate the practicality of CMs for intraoperative toric intraocular lens (IOL) alignment. SETTING: LENSAR facility, Orlando, Florida, USA. DESIGN: Laboratory study. METHODS: The biomechanical strength of the capsulotomy with CMs was tested under two different load orientations (orthogonal to or in-line with CMs). Thirty-six porcine eyes were randomly assigned to three treatment cohorts: (1) standard capsulotomy with no CMs, (2) capsulotomy with CMs for in-line tensile testing and (3) capsulotomy with CMs for orthogonal tensile testing. Study parameters were capsulotomy break force and maximum extensibility. The ease of using CMs for toric IOL alignment was also evaluated. RESULTS: There was no significant difference between the mean break force for standard capsulotomy (180.57 mN ± 22 [SD]), capsulotomy with CMs with orthogonal load (178.04 ± 20 mN, P = 1.000), and with in-line load (181.05 ± 15 mN, P = 1.000). Likewise, the mean extensibility at the break point for standard capsulotomy (6.47 ± 0.33 mm) was equivalent to the mean extensibility with CMs with orthogonal load (6.49 ± 0.45 mm, P = 1.000) and with in-line load (6.3 ± 0.47 mm, P = .960). In the implanted eyes, toric IOLs were found to be easily aligned with the CMs. CONCLUSION: The femtosecond laser capsulotomies with CMs were equivalent in tensile strength and extensibility to standard femtosecond laser capsulotomies and showed high potential for effective alignment of toric IOLs.


Assuntos
Marcadores Fiduciais , Cápsula do Cristalino/fisiologia , Implante de Lente Intraocular , Capsulotomia Posterior , Resistência à Tração/fisiologia , Animais , Fenômenos Biomecânicos , Lentes Intraoculares , Suínos
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