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1.
Optom Vis Sci ; 100(2): 164-169, 2023 02 01.
Artigo em Inglês | MEDLINE | ID: mdl-36728653

RESUMO

SIGNIFICANCE: There is a clinical necessity for dry eye disease treatments that perform across a broad range of presenting patient severities. Varenicline solution nasal spray (VNS), a unique cholinergic agonist ocular surface-sparing nasal spray therapy, demonstrated significant improvement in both signs and symptoms of dry eye disease in subjects with mild, moderate, and severe symptoms as the clinical studies enrolled a more real-world patient population. PURPOSE: This study evaluated efficacy outcomes for VNS in patients with mild-moderate and severe dry eye disease. METHODS: An analysis of integrated data from two randomized clinical trials, ONSET-1 (NCT03636061) and ONSET-2 (NCT04036292) (vehicle control [VC], n = 294; VNS 0.03 mg, n = 308), was performed. Adults 22 years or older with dry eye disease, Ocular Surface Disease Index score of ≥23, corneal fluorescein staining score of ≥2 in ≥1 regions/≥4 all regions, and Schirmer Test Score (STS) of ≤10 mm (no restrictions on Eye Dryness Score [EDS]) were included in this study. Efficacy was evaluated using analysis of covariance among pre-specified subgroups of mild-moderate and severe baseline disease severity defined by STS (≤5 vs. >5) and EDS (<60 vs. ≥60). Consistency of effect was evaluated by interaction tests. RESULTS: No treatment-subgroup interactions were observed for all end points ( P > .05). The odds of achieving a ≥10-mm improvement in STS for VNS versus VC for patients with baseline STS ≤5 and >5 were 3.4(95% confidence interval, 2.0 to 5.6) and 2.3(1.3 to 4.0) and for EDS of <60 and ≥60 were 3.4(1.9 to 6.1) and 2.5(1.5 to 4.0). Least-squares mean treatment/VC differences in change from baseline in EDS for patients with baseline STS ≤5 or >5 were -7.4(95% confidence interval, -12.5 to -2.4) and -2.8(-8.7 to 3.1); EDS of <60 and ≥60 were -2.9(-8.3 to 2.5) and -8.1(-13.6 to -2.6). CONCLUSIONS: Compared with VC, VNS improved tear production and patient-reported symptoms in patients with dry eye disease, demonstrating consistency of effect regardless of initial presenting severity.


Assuntos
Síndromes do Olho Seco , Sprays Nasais , Adulto , Humanos , Síndromes do Olho Seco/tratamento farmacológico , Soluções Oftálmicas , Gravidade do Paciente , Lágrimas , Resultado do Tratamento , Vareniclina/uso terapêutico
2.
J Cataract Refract Surg ; 48(6): 730-740, 2022 06 01.
Artigo em Inglês | MEDLINE | ID: mdl-34753878

RESUMO

Cataracts are a leading cause of preventable blindness globally. Although care varies between developing and industrialized countries, surgery is the single effective approach to treating cataracts. From the earliest documented primitive cataract removals to today's advanced techniques, cataract surgery has evolved dramatically. As surgical techniques have developed, so have approaches to surgical pain management. With current cataract surgical procedures and advanced technology, anesthesia and intraoperative pain management have shifted to topical/intracameral anesthetics, with or without low-dose systemic analgesia and anxiolysis. Despite this, pain and discomfort persist in some patients and are underappreciated in modern cataract surgery. Although pain management has progressed, opioids remain a mainstay intraoperatively and, to a lesser extent, postoperatively. This article discusses the evolution of pain management in cataract surgery, particularly the use of opioids and the associated risks as well as how ophthalmology can have a positive impact on the opioid crisis.


Assuntos
Catarata , Oftalmologia , Analgésicos Opioides/uso terapêutico , Anestesia Local/métodos , Anestésicos Locais/uso terapêutico , Catarata/complicações , Humanos , Dor , Manejo da Dor/efeitos adversos , Dor Pós-Operatória/tratamento farmacológico
4.
Am J Ophthalmol ; 215: 56-65, 2020 07.
Artigo em Inglês | MEDLINE | ID: mdl-32222367

RESUMO

PURPOSE: To evaluate the efficacy and safety of a topical ophthalmic suspension combination of povidone-iodine 0.6% (PVP-I) and dexamethasone 0.1% (DEX) for infectious and inflammatory components of bacterial conjunctivitis. DESIGN: Randomized, double-masked, multicenter, phase 3 clinical trial. METHODS: Subjects of all ages (those <3 months had to be full-term) with a diagnosis of bacterial conjunctivitis were randomized 3:1:3 to either PVP-I/DEX, PVP-I alone, or placebo. The primary endpoint was clinical resolution in the study eye, and the key secondary efficacy endpoint was bacterial eradication, both at the day 5 visit. Adverse events (AEs) were documented at all visits. RESULTS: Overall, 753 subjects were randomized (intent-to-treat [ITT] population; PVP-I/DEX [n = 324]; PVP-I [n = 108]; placebo [n = 321]); mean and standard deviation (SD) age was 44.3 (22.9) years, and most were female (61.2%) and white (78.1%). In all treatment groups, mean treatment compliance was >98%. The modified ITT population for the efficacy analysis comprised 526 subjects. In the study eye at the day 5 visit, clinical resolution was achieved by 50.5% (111/220) subjects in the PVP-I/DEX group vs 42.8% (95/222) in the placebo group (P = .127), and bacterial eradication was achieved by 43.3% (94/217) and 46.8% (102/218), respectively (P = .500). Treatment-emergent AEs were experienced by 32.8% (106/323), 39.8% (43/108), and 19.0% (61/321) of subjects in the safety population treated with PVP-I/DEX, PVP-I, and placebo, respectively (most mild in severity). CONCLUSION: In this study, PVP-I/DEX did not demonstrate additional benefit in clinical efficacy compared with placebo in subjects with bacterial conjunctivitis.


Assuntos
Antibacterianos/uso terapêutico , Anti-Infecciosos Locais/uso terapêutico , Conjuntivite Bacteriana/tratamento farmacológico , Dexametasona/uso terapêutico , Infecções Oculares Bacterianas/tratamento farmacológico , Glucocorticoides/uso terapêutico , Povidona-Iodo/uso terapêutico , Doença Aguda , Administração Oftálmica , Adulto , Bactérias/isolamento & purificação , Conjuntivite Bacteriana/microbiologia , Conjuntivite Bacteriana/fisiopatologia , Método Duplo-Cego , Quimioterapia Combinada , Infecções Oculares Bacterianas/microbiologia , Infecções Oculares Bacterianas/fisiopatologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Soluções Oftálmicas , Estudos Prospectivos , Resultado do Tratamento
5.
Curr Eye Res ; 45(4): 450-458, 2020 04.
Artigo em Inglês | MEDLINE | ID: mdl-31532699

RESUMO

Purpose: Corneal collagen crosslinking (CXL) through an intact epithelium (epi-on) at high irradiance could potentially improve patient comfort, visual recovery, and clinical workflow compared to conventional epi-off CXL. However, intact epithelium limits stromal delivery of the oxygen, photosensitizer, and ultraviolet-A (UV-A) radiation needed to drive CXL. This ex vivo study evaluated three different epi-on CXL protocols compared to positive and negative controls, specifically focusing on the impact of supplemental oxygen. Endpoints included stromal oxygen levels, stiffness of crosslinked tissue, and acute flattening of whole eyes.Materials & Methods: Ex vivo porcine eyes were held in a custom environmental chamber. Intrastromal oxygen levels were continuously measured before, during, and after UV illumination by a fiberoptic probe inserted into a laser-cut flap. Accelerated, high irradiance, epi-on CXL protocols using riboflavin formulated with benzalkonium chloride (BAC) were studied, with and without supplemental oxygen. These were compared to an alternate, low irradiance, epi-on protocol using riboflavin formulated with sodium iodide. Both negative (no CXL) and positive (epi-off modified Dresden protocol) controls were performed. Post-CXL elastic modulus was measured using extensiometry and anterior tangential curvature was measured using a Scheimpflug tomographer.Results: Protocols including supplemental oxygen resulted in an approximately 5-fold increase in stromal oxygen levels prior to CXL. During epi-on, high-irradiance UV-A delivery under hyperoxic conditions, an aerobic state was maintained. Conversely, under normoxic conditions, stromal oxygen rapidly depleted to 0-5% for all other protocols. The combination of supplemental oxygen, BAC formulation, and high-irradiance UV-A resulted in the largest biomechanical changes and most pronounced flattening effects of the three epi-on protocols.Conclusions: Ex vivo analysis of stromal oxygen levels, corneal stiffness, and acute anterior curvature change indicates that simultaneous optimization of the oxygen environment, riboflavin formulation, and UV-A protocol can significantly increase the effects of corneal collagen crosslinking.


Assuntos
Colágeno/farmacologia , Substância Própria/metabolismo , Reagentes de Ligações Cruzadas/farmacologia , Ceratocone/metabolismo , Oxigênio/metabolismo , Fotoquimioterapia/métodos , Riboflavina/farmacologia , Animais , Substância Própria/diagnóstico por imagem , Topografia da Córnea , Modelos Animais de Doenças , Ceratocone/diagnóstico , Ceratocone/tratamento farmacológico , Fármacos Fotossensibilizantes/farmacologia , Suínos , Raios Ultravioleta
6.
J Ocul Pharmacol Ther ; 36(2): 75-87, 2020 03.
Artigo em Inglês | MEDLINE | ID: mdl-31755807

RESUMO

Background: Iontophoresis is a noninvasive delivery system designed to overcome barriers to ocular penetration of topical ophthalmic medications by employing a low-amplitude electrical current to promote the migration of a charged drug substance across biological membranes. Trans-scleral iontophoresis of dexamethasone phosphate has demonstrated dramatically increased intraocular concentrations of dexamethasone in rabbit ocular tissues compared with topical instillation, including 50- to 100-fold greater aqueous humor concentrations. Methods: This article reviews available data on recent clinical applications of iontophoretic ophthalmic drug delivery. Results: The EyeGate II delivery system (EGDS) is a trans-scleral iontophoresis system that has been used in conjunction with EGP-437, a proprietary-charged formulation of dexamethasone phosphate for iontophoretic delivery. In patients with noninfectious anterior uveitis, EGP-437, delivered through 2 iontophoretic treatments using the EGDS, demonstrated similar efficacy to topical prednisolone acetate 1% eye drops instilled 8 times daily over 28 days, suggesting the potential to decrease or eliminate the need for daily dosing of topical steroids in this patient population. Other applications for EGP-437 delivered through the EGDS that have been explored in clinical trials include treatment of dry eye, postsurgical inflammation and pain, and scleritis. In addition, transcorneal iontophoresis has been used outside of the United States to enhance riboflavin penetration in patients undergoing corneal cross-linking as therapy for progressive keratoconus. Conclusions: The reviewed studies demonstrate the feasibility of using iontophoresis to enhance drug delivery to ocular tissues and support the potential of this noninvasive technique across a range of ophthalmic indications.


Assuntos
Sistemas de Liberação de Medicamentos , Síndromes do Olho Seco/tratamento farmacológico , Inflamação/tratamento farmacológico , Soluções Oftálmicas/uso terapêutico , Dor/tratamento farmacológico , Uveíte Anterior/tratamento farmacológico , Animais , Humanos , Iontoforese , Soluções Oftálmicas/administração & dosagem
7.
Am J Ophthalmol ; 211: 76-86, 2020 03.
Artigo em Inglês | MEDLINE | ID: mdl-31726034

RESUMO

PURPOSE: To evaluate the safety and efficacy of dexamethasone phosphate ophthalmic solution (EGP-437) delivered by a transscleral iontophoresis delivery system (EyeGate II) compared to that of topical prednisolone acetate 1% (PA 1%) in subjects with noninfectious anterior uveitis. DESIGN: Prospective, randomized, double-masked, parallel group, noninferiority clinical trial. METHODS: A total of 193 subjects with active noninfectious anterior uveitis (anterior chamber [AC] cell count ≥11 cells) were randomized to EGP-437 delivered by iontophoresis (days 0 and 7) or self-administered PA 1% daily (tapered schedule, days 0-28). Masking was maintained with placebo iontophoresis or eye drops. The primary efficacy endpoint was the proportion of subjects with an AC cell count of zero on day 14. Noninferiority of EGP-437 was defined if the lower limit of the confidence interval (CI) for the difference (EGP-437 minus PA 1%) was less than -10%. RESULTS: At day 14, 32 of 96 EGP-437 subjects (33.3%) and 32 of 97 PA 1% subjects (33.0%) had an AC cell count of zero (difference, 0.34; 95% CI, -12.94 to 13.63; P = 0.064). Efficacy trended better with EGP-437 among patients with more severe baseline uveitis (AC cell count >25). Safety and tolerability were good with both treatments. EGP-437 subjects experienced fewer IOP elevations ≥6 mm Hg versus PA 1% subjects (13 vs 24 incidents, respectively, through day 28). CONCLUSIONS: Despite clinically similar response rates, statistical noninferiority of EGP-437 versus a tapered regimen of PA 1% was not achieved. Numerical trends suggesting fewer IOP elevations with EGP-437, similar efficacy overall, and possibly better efficacy in more severe disease warrant further study.


Assuntos
Dexametasona/análogos & derivados , Sistemas de Liberação de Medicamentos , Glucocorticoides/administração & dosagem , Iontoforese/métodos , Prednisolona/análogos & derivados , Uveíte Anterior/tratamento farmacológico , Administração Oftálmica , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Câmara Anterior/patologia , Contagem de Células , Criança , Dexametasona/administração & dosagem , Método Duplo-Cego , Feminino , Humanos , Pressão Intraocular/efeitos dos fármacos , Masculino , Pessoa de Meia-Idade , Soluções Oftálmicas , Prednisolona/administração & dosagem , Estudos Prospectivos , Resultado do Tratamento , Uveíte Anterior/diagnóstico , Uveíte Anterior/fisiopatologia
8.
Am J Ophthalmol ; 200: 130-137, 2019 04.
Artigo em Inglês | MEDLINE | ID: mdl-30653957

RESUMO

PURPOSE: To evaluate netarsudil 0.02% ophthalmic solution in patients with open-angle glaucoma (OAG) and ocular hypertension (OHT). DESIGN: Double-masked, randomized, multicenter, parallel-group, noninferiority clinical study. METHODS: After a washout of all prestudy ocular hypotensive medications, 756 eligible patients with elevated IOP were randomized to receive netarsudil 0.02% once a day (q.d.) (251); netarsudil 0.02% twice a day (b.i.d.) (254); or timolol 0.5% b.i.d. (251) for 12 months, as well as a noninterventional Corneal Observation Study (COS) for patients manifesting cornea verticillata. RESULTS: On treatment, mean IOP at 8:00 AM decreased from a baseline IOP of 22.5-22.6 mm Hg to 17.9-18.8 mm Hg, 17.2-18.0 mm Hg, and 17.5-17.9 mm Hg for netarsudil q.d., netarsudil b.i.d., and timolol, respectively, over 12 months. The most frequently reported adverse events (AEs) were ocular, with the most frequent ocular AE being conjunctival hyperemia, with an incidence of 61%, 66%, and 14%, respectively. The next most frequent AEs were corneal deposits (corneal verticillata), with an incidence of 26%, 25%, and 1%, respectively, and conjunctival hemorrhage (typically petechial), with an incidence of 20%, 19%, and 1%, respectively. All 3 AEs were generally scored as mild, with conjunctival hyperemia and/or hemorrhage appearing sporadically during the study. In the observational follow-up component of this study, there was no clinically meaningful impact of corneal verticillata on visual function in affected patients. CONCLUSIONS: In this randomized, double-masked trial, once-daily dosing of netarsudil 0.02% was effective, consistently lowering IOP through 12 months, and was tolerated by the majority of patients.


Assuntos
Anti-Hipertensivos/uso terapêutico , Benzoatos/uso terapêutico , Glaucoma de Ângulo Aberto/tratamento farmacológico , Pressão Intraocular/efeitos dos fármacos , beta-Alanina/análogos & derivados , Quinases Associadas a rho/antagonistas & inibidores , Administração Oftálmica , Antagonistas Adrenérgicos beta/administração & dosagem , Antagonistas Adrenérgicos beta/uso terapêutico , Adulto , Idoso , Anti-Hipertensivos/administração & dosagem , Anti-Hipertensivos/efeitos adversos , Benzoatos/administração & dosagem , Benzoatos/efeitos adversos , Método Duplo-Cego , Feminino , Glaucoma de Ângulo Aberto/diagnóstico , Glaucoma de Ângulo Aberto/fisiopatologia , Humanos , Masculino , Pessoa de Meia-Idade , Hipertensão Ocular/diagnóstico , Hipertensão Ocular/tratamento farmacológico , Hipertensão Ocular/fisiopatologia , Soluções Oftálmicas , Timolol/administração & dosagem , Timolol/uso terapêutico , Resultado do Tratamento , beta-Alanina/administração & dosagem , beta-Alanina/efeitos adversos , beta-Alanina/uso terapêutico
9.
JAMA Ophthalmol ; 137(2): 185-193, 2019 02 01.
Artigo em Inglês | MEDLINE | ID: mdl-30422157

RESUMO

Importance: Determining factors associated with endothelial cell loss after Descemet stripping automated endothelial keratoplasty (DSAEK) could improve long-term graft survival. Objective: To evaluate the associations of donor, recipient, and operative factors with endothelial cell density (ECD) 3 years after DSAEK in the Cornea Preservation Time Study. Design, Setting, and Participants: This cohort study was a secondary analysis of data collected in a multicenter, double-masked, randomized clinical trial. Forty US clinical sites with 70 surgeons participated, with donor corneas provided by 23 US eye banks. Individuals undergoing DSAEK for Fuchs dystrophy or pseudophakic/aphakic corneal edema were included. Interventions: The DSAEK procedure, with random assignment of a donor cornea with a preservation time of 0 to 7 days or 8 to 14 days. Main Outcomes and Measures: Endothelial cell density at 3 years as determined by a reading center from eye bank and clinical specular or confocal central endothelial images. Results: The study included 1090 participants (median age, 70 years) with 1330 affected eyes (240 bilateral cases [22.0%]), who underwent DSAEK for Fuchs dystrophy (1255 eyes [94.4%]) or pseudophakic/aphakic corneal edema (PACE) (75 eyes [5.6%]). Of these, 801 eyes (60.2%) belonged to women and 1207 (90.8%) to white individuals. A total of 749 participants (913 eyes; 164 [21.9%] bilateral cases) had functioning grafts with acceptable endothelial images preoperatively and at 3 years postoperatively and were included in this analysis. Factors associated with a lower ECD at 3 years (estimated effect with 99% CI) in the final multivariable model included donors with diabetes (-103 [-196 to -9] cells/mm2), lower screening ECD (-234 [-331 to -137] per 500 cells/mm2), recipient diagnosis of PACE (-257 [-483 to -31] in cells/mm2), and operative complications (-324 [-516 to -133] in cells/mm2). Endothelial cell loss (ECL) from a preoperative measurement to a 3-year postoperative measurement was 47% (99% CI, 42%-52%) for participants receiving tissue from donors with diabetes vs 43% (99% CI, 39%-48%) without diabetes; it was 53% (99% CI, 44%-62%) for participants diagnosed with PACE vs 44% (99% CI, 39%-49%) for those diagnosed with Fuchs dystrophy, and 55% (99% CI, 48%-63%) in participants who experienced operative complications vs 44% (99% CI, 39%-48%) in those who did not. No other donor, recipient, or operative factors were significantly associated with 3-year ECD. Conclusions and Relevance: Donor diabetes, lower screening ECD, a PACE diagnosis in the recipient, and operative complications were associated with lower ECD at 3 years after DSAEK surgery and may be associated with long-term graft success. While causation cannot be inferred, further studies on the association of donor diabetes and PACE in recipients with lower 3-year ECD warrant further study.


Assuntos
Córnea , Perda de Células Endoteliais da Córnea/diagnóstico , Ceratoplastia Endotelial com Remoção da Lâmina Limitante Posterior , Preservação de Órgãos/métodos , Doadores de Tecidos , Transplantados , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Contagem de Células , Criança , Edema da Córnea/cirurgia , Método Duplo-Cego , Endotélio Corneano/patologia , Feminino , Distrofia Endotelial de Fuchs/cirurgia , Sobrevivência de Enxerto/fisiologia , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Fatores de Risco , Estudos de Tempo e Movimento
10.
Ophthalmic Plast Reconstr Surg ; 33(3S Suppl 1): S6-S9, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-26237531

RESUMO

Excised redundant, forniceal "conjunctival" tissue from a 67-year-old man who experienced a chemical injury to his OS 25 years earlier was evaluated histopathologically with the hematoxylin-eosin, periodic acid Schiff (PAS) with and without diastase, mucicarmine, and Alcian blue methods. Additional immunoperoxidase testing for gross cystic disease fluid protein-15 (GCDFP-15) was undertaken. Non-keratinizing squamous epithelium composed of 8 to 10 layers of swollen keratinocytes without goblet cells surmounted a variably dense and well-vascularized collagenized lamina propria deep to which, in submucosal fibroadipose tissue, was embedded an accessory gland. The acini of the gland were composed of both GCDFP-15-positive serous cells and mucicarmine-positive goblet cells, indicating they were seromucinous rather than entirely serous, as is characteristic of normal lacrimal glandular tissue. Different features of the surface epithelium, the lamina propria, and the submucosa can separate the conjunctival and oral mucous membranes. A close analysis of the cytologic composition of associated accessory glands can reinforce the correct diagnosis of an oral mucous membrane graft when the past surgical history is unclear, because only serous cells but not mucocytes comprise the lacrimal glandular units.


Assuntos
Queimaduras Químicas/cirurgia , Túnica Conjuntiva/patologia , Ectrópio/patologia , Queimaduras Oculares/cirurgia , Mucosa Bucal/patologia , Mucosa Bucal/transplante , Procedimentos Cirúrgicos Oftalmológicos/métodos , Idoso , Queimaduras Químicas/complicações , Túnica Conjuntiva/lesões , Túnica Conjuntiva/cirurgia , Ectrópio/etiologia , Ectrópio/cirurgia , Queimaduras Oculares/complicações , Humanos , Masculino , Procedimentos de Cirurgia Plástica/métodos
11.
Surv Ophthalmol ; 62(3): 286-301, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-27890620

RESUMO

Drugs across many pharmacologic classes induce corneal epithelial changes. Many of these drugs have cationic amphiphilic structures, with a hydrophobic ring and hydrophilic cationic amine side chain that allow them to cross cell membranes. These drugs lead to intracellular phospholipid accumulation, often manifested in the cornea by vortex keratopathy, with no effect on visual acuity and few ocular symptoms. Other drugs, notably antineoplastic agents, produce a fine diffuse corneal haze, sometimes accompanied by decreased vision that can be dose limiting. Still other medications cause crystalline epithelial precipitation that might require debridement for resolution. An understanding of the variety of drugs involved, the multiple mechanisms responsible, and the systemic diseases that produce similar changes can lead to improved management strategies for patients with corneal epithelial deposits. In most cases, drug therapy need not be modified or discontinued, but if visual acuity is affected, close collaboration with the prescribing physician can result in determining an optimized dose that treats systemic disease and minimizes these deposits. Additionally, close monitoring might be required if the drug is also associated with other ocular findings, such as optic neuropathy or retinopathy.


Assuntos
Doenças da Córnea/induzido quimicamente , Epitélio Corneano/efeitos dos fármacos , Doenças da Córnea/patologia , Epitélio Corneano/patologia , Humanos
12.
J Cataract Refract Surg ; 40(12): 2057-66, 2014 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-25465686

RESUMO

PURPOSE: To evaluate the effectiveness of a hydrogel sealant versus a suture in preventing fluid egress after wound leakage in cataract surgery. SETTING: Twenty-four ophthalmic clinical practices in the United States. DESIGN: Prospective randomized parallel-arm controlled multicenter subject-masked study. METHODS: Healthy patients having uneventful clear corneal incision (CCI) cataract surgery were eligible for the study. Spontaneous and provoked fluid egress from wounds was evaluated at the time of surgery using a calibrated force gauge. Eyes with leakage were randomized to receive a hydrogel sealant (Resure) or a nylon suture at the main incision site. Incision leakage was reevaluated 1, 3, 7, and 28 days postoperatively. RESULTS: Of 500 eyes, 488 had leakage at the time of cataract surgery. The leak was spontaneous in 244 cases (48.8%), and 488 (97.6%) of all incisions leaked with 1.0 ounce or less of applied force. After randomization, 12 (4.1%) of 295 eyes in the sealant group and 60 (34.1%) of 176 eyes in the suture group had wound leakage with provocation (P<.0001). The overall incidence of adverse ocular events was statistically significantly lower in the sealant group than in the suture group (P<.05). CONCLUSIONS: In this study, 97.6% of CCIs leaked after cataract surgery. The hydrogel sealant was safe and effective and better than a suture for the intraoperative management of CCIs with leakage as seen on Seidel testing and for the prevention of postoperative fluid egress.


Assuntos
Extração de Catarata , Hidrogel de Polietilenoglicol-Dimetacrilato , Complicações Pós-Operatórias/prevenção & controle , Deiscência da Ferida Operatória/prevenção & controle , Técnicas de Sutura , Adesivos Teciduais/uso terapêutico , Adulto , Idoso , Idoso de 80 Anos ou mais , Córnea/efeitos dos fármacos , Córnea/cirurgia , Método Duplo-Cego , Feminino , Humanos , Pressão Intraocular/fisiologia , Implante de Lente Intraocular , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Deiscência da Ferida Operatória/etiologia , Acuidade Visual/fisiologia , Cicatrização/efeitos dos fármacos
14.
J Cataract Refract Surg ; 39(4): 511-8, 2013 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-23434217

RESUMO

PURPOSE: To develop and evaluate a calibrated force gauge designed to simulate the effect of patient-induced manipulation of the eye with resultant elevation of intraocular pressure (IOP) and use the device to determine the stability of cataract incisions. SETTING: Three private practice study sites. DESIGN: Clinical trials. METHODS: A calibrated force gauge was developed to apply controlled and quantifiable amounts of force to the eye. In study 1, the calibrated force gauge was used to evaluate the change in IOP during application of 1 oz of external force in a group of healthy volunteers. In studies 2 and 3, the calibrated force gauge was used to assess wound leakage of clear corneal incisions that were subjected to stromal hydration or sutures, respectively. RESULTS: In study 1, with the application of 1.00 oz of external force, the mean IOP rose from a baseline of 17.49 mm Hg to 43.44 mm Hg. In study 2 (stromal hydration) using up to 1.00 oz of force, the leak rate was 67% for the main incision. The overall leak rate for study 3 (sutures) using up to 1.00 oz of force was 23.8%. No adverse events or serious adverse events occurred during these studies. CONCLUSIONS: Study 1 confirmed that 1.00 oz of force is a realistic approximation of the amount of force a patient's eye may experience during rubbing. After clear corneal cataract surgery, the application of 1.00 oz of force to the ocular surface for approximately 2 to 3 seconds may simulate the propensity for postoperative wound leak resulting from patient manipulation.


Assuntos
Córnea/cirurgia , Pressão Intraocular/fisiologia , Massagem , Facoemulsificação/métodos , Complicações Pós-Operatórias , Deiscência da Ferida Operatória/fisiopatologia , Transdutores de Pressão , Adulto , Calibragem , Feminino , Humanos , Implante de Lente Intraocular , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Deiscência da Ferida Operatória/etiologia , Tomografia de Coerência Óptica , Tonometria Ocular , Cicatrização/fisiologia , Adulto Jovem
17.
Am J Ophthalmol ; 151(3): 420-6.e1, 2011 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-21145532

RESUMO

PURPOSE: To evaluate the efficacy and safety of twice-daily, preservative-free ketorolac 0.45% (Acuvail; Allergan, Inc, Irvine, California, USA) administration for treatment of inflammation and pain after cataract surgery. DESIGN: Prospective, randomized trial. METHODS: Two multicenter, double-masked studies randomized 511 cataract surgery patients (2:1) to receive twice-daily ketorolac 0.45% or vehicle in the operative eye for 16 days, beginning 1 day before surgery. The primary efficacy end point was the percentage of patients with a summed ocular inflammation score of 0 for anterior chamber cell and flare on postoperative day 14. The main secondary efficacy end point was the percentage of patients with no pain on postoperative day 1. RESULTS: On day 14, 52.5% of ketorolac patients and 26.5% of vehicle patients had an summed ocular inflammation score of 0 (P < .001). On day 1, 72.4% of ketorolac patients and 39.7% of vehicle patients had a pain score of 0 (P < .001). Median time to pain resolution was 1 day in the ketorolac group and 2 days in the vehicle group (P < .001). The percentage of ketorolac and vehicle patients who had a +3-line or more improvement in best-corrected visual acuity from baseline was 60.5% versus 44.0% on day 14 (P = .002). Overall, adverse events were more prevalent in the vehicle group than in the ketorolac group (48.5% vs 35.2%; P = .004). Burning or stinging (per a composite Medical Dictionary for Regulatory Activities) was reported by 1.5% of ketorolac patients and 0.6% of vehicle patients. CONCLUSIONS: Twice-daily ketorolac 0.45% was well tolerated and effectively treated inflammation and pain following cataract surgery.


Assuntos
Anti-Inflamatórios não Esteroides/administração & dosagem , Dor Ocular/tratamento farmacológico , Cetorolaco/administração & dosagem , Facoemulsificação , Uveíte Anterior/tratamento farmacológico , Adulto , Idoso , Idoso de 80 Anos ou mais , Anti-Inflamatórios não Esteroides/efeitos adversos , Método Duplo-Cego , Dor Ocular/etiologia , Feminino , Humanos , Cetorolaco/efeitos adversos , Implante de Lente Intraocular , Masculino , Pessoa de Meia-Idade , Medição da Dor , Conservantes Farmacêuticos/administração & dosagem , Estudos Prospectivos , Resultado do Tratamento , Uveíte Anterior/etiologia , Acuidade Visual/fisiologia
18.
J Cataract Refract Surg ; 37(1): 113-21, 2011 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-21183106

RESUMO

PURPOSE: To compare the safety and efficacy of a hydrogel bandage and a collagen corneal shield in providing wound protection and relief of pain/discomfort in the acute period after uneventful unilateral clear corneal phacoemulsification cataract surgery with foldable intraocular lens (IOL) implantation. SETTING: Seventeen investigational sites in the United States. DESIGN: Prospective randomized single-masked parallel study. METHODS: The study comprised patients scheduled to have unilateral clear corneal cataract surgery with posterior chamber intraocular lens implantation. The patients were examined preoperatively and frequently for 30 days postoperatively. The design was a noninferiority study of the 2 primary endpoints, device performance and maximum reported postoperative pain. RESULTS: The device performance success was 78.6% (228/290) for the hydrogel bandage and 26.5% (26/98) for the corneal shield (P<.0001 for noninferiority). Analyses indicated that the hydrogel bandage was superior to the corneal shield in device performance (P<.001; difference = 52.1%; 95% confidence interval, 41.6%-61.4%). The maximum postoperative pain/discomfort score of the hydrogel bandage (mean 1.3 ± 1.8 [SD]; scale 0 to 10) was noninferior to that of the corneal shield (1.1 ± 1.6) in the first 4 hours after surgery (P<.001). Adverse events in the cataract surgeries were reported in 22.2% (70/316) and 36.5% (38/104) of hydrogel bandage patients and corneal shield patients, respectively (P = .0045). CONCLUSION: The hydrogel bandage was safe and effective for ocular surface protection and relief of pain/discomfort when applied topically to clear corneal incisions used in cataract or IOL implantation surgery. FINANCIAL DISCLOSURE: No author has a financial or proprietary interest in any material or method mentioned. Additional disclosures are found in the footnotes.


Assuntos
Curativos Hidrocoloides , Colágeno , Córnea/cirurgia , Facoemulsificação , Cuidados Pós-Operatórios/métodos , Infecção da Ferida Cirúrgica/prevenção & controle , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Implante de Lente Intraocular , Masculino , Pessoa de Meia-Idade , Dor Pós-Operatória/terapia , Satisfação do Paciente , Estudos Prospectivos , Método Simples-Cego , Resultado do Tratamento , Adulto Jovem
19.
Clin Ophthalmol ; 4: 1505-14, 2010 Dec 10.
Artigo em Inglês | MEDLINE | ID: mdl-21191448

RESUMO

PURPOSE: The purpose of this study is to characterize the bacterial flora of the ocular and periocular surface in cataract surgery patients and to determine the prevalence of methicillin resistance among staphylococcal isolates obtained from health care workers (HCWs) and non-HCWs. METHODS: In this prospective, multicenter, case series study, eyelid and conjunctival cultures were obtained from the nonoperative eye of 399 consecutive cataract patients on the day of surgery prior to application of topical anesthetics, antibiotics, or antiseptics. Speciation and susceptibility testing were performed at the Dean A. McGee Eye Institute. Logistic regression was utilized to evaluate whether any factors were significant in predicting the presence of methicillin-resistant staphylococcal isolates. RESULTS: Staphylococcus epidermidis (62.9%), followed by S. aureus (14.0%), was the most frequently isolated organism. Methicillin-resistant S. epidermidis accounted for 47.1% (178/378) of S. epidermidis isolates, and methicillin-resistant S. aureus accounted for 29.5% (26/88) of S. aureus isolates. Methicillin-resistant staphylococcal isolates were found in 157 of 399 (39.3%) patients, the majority (89.2%) of whom were non-HCWs. The likelihood of being colonized with methicillin-resistant organisms increased with age (odds ratio [OR], 1.27; 95% confidence interval [CI]: 1.02-1.58; P = 0.04) but decreased with diabetes (OR, 0.51; 95% CI: 0.29-0.89; P = 0.02). Being a HCW (OR, 1.25; 95% CI: 0.61-2.58; P = 0.54) was not a risk factor for colonization with methicillin-resistant organisms. CONCLUSION: Patients without exposure to health care environments are as likely as HCWs to be colonized with methicillin-resistant organisms. Increasing methicillin resistance with age may partially explain the increased risk of endophthalmitis reported with older age.

20.
Curr Med Res Opin ; 25(8): 1953-61, 2009 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-19552618

RESUMO

OBJECTIVE: Acute conjunctivitis is an extremely common condition and can be associated with significant morbidity and economic burden. Despite this, considerable controversy exists pertaining to the prevalence, diagnosis, management, and treatment of the condition. A panel of ophthalmology experts was assembled to review and discuss the current evidence based literature as it pertains to each of these persistent controversies. METHODS AND SCOPE: An acute conjunctivitis round table symposium was convened at the American Academy of Ophthalmology meeting in Atlanta, November 2008. The expert panelists consisted of four academic ophthalmologists in the field of cornea and external disease, whose discussion was informed by an English language literature survey carried out on the PubMed database for the period of January 1972 to October 2008. A narrative summary was generated from the literature review and direct transcription of this event, from which this Review article was developed. FINDINGS AND CONCLUSIONS: Considerable light has been shed on acute microbial conjunctivitis and especially those cases caused by adenovirus. Many of the myths that have perpetuated for years have been debunked by emerging evidence. The advent and the implementation of better diagnostic tools and anti-viral medications will help clinicians to improve their diagnostic accuracy, improve management and treatment decisions, and ultimately benefit patients while saving overall healthcare costs.


Assuntos
Conjuntivite , Doença Aguda , Conjuntivite/diagnóstico , Conjuntivite/tratamento farmacológico , Conjuntivite/economia , Conjuntivite/epidemiologia , Conjuntivite/fisiopatologia , Erros de Diagnóstico , Herpes Simples/complicações , Humanos
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