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1.
Ophthalmic Surg Lasers Imaging Retina ; 46(4): 451-6, 2015 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-25970866

RESUMEN

BACKGROUND AND OBJECTIVE: To investigate cases of retained intraocular perfluoro-n-octane (PFO) after pars plana vitrectomy (PPV) for retinal detachment (RD). PATIENTS AND METHODS: Retrospective, noncomparative case series of six eyes with retained intraocular PFO after RD repair. Clinical data were supplemented with an experimental silicone eye model. RESULTS: A cluster of six cases of retained intraocular PFO after PPV for RD repair were noted shortly after transitioning to valved cannulas. PFO was noted in the anterior chamber (AC) and/or vitreous and removed with AC paracentesis, AC wash-out, and/or PPV. A silicone eye model demonstrated that PFO levels are maintained anterior to cannula insertion with valved cannulas only. CONCLUSION: The authors hypothesize that anterior PFO fill using valved cannulas can lead to sequestration within the AC, zonules, ciliary sulcus, ciliary teeth, and/or capsular bag. They suggest vigilance in not overfilling PFO, particularly when transitioning to use of valved cannulas, to minimize the risk of intraocular retention.


Asunto(s)
Endotaponamiento , Cuerpos Extraños en el Ojo/etiología , Fluorocarburos , Desprendimiento de Retina/cirugía , Vitrectomía/métodos , Adulto , Anciano , Femenino , Humanos , Masculino , Microburbujas , Persona de Mediana Edad , Desprendimiento de Retina/fisiopatología , Estudios Retrospectivos , Agudeza Visual/fisiología , Vitrectomía/instrumentación , Cuerpo Vítreo/química
2.
Retina ; 35(6): 1128-34, 2015 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-25635575

RESUMEN

PURPOSE: After the recent approval of ocriplasmin by the Food and Drug Administration, postmarketing safety concerns have been raised by the vitreoretinal community. The American Society of Retina Specialists Therapeutic Surveillance Committee was commissioned to monitor postmarketing drug-related and device-related adverse events. The purpose of this report is to analyze the postmarketing safety experience in the context of available premarketing safety data. METHODS: Periodic aggregate safety reports consisting of premarketing, or clinical trial, data (n = 999 injections) and postmarketing reports through July 16, 2013 (n = 4,387 injections), were retrospectively analyzed by the TSC. The aggregate data were analyzed to classify adverse events, and the postmarketing safety data for each event type were compared with the premarketing data. RESULTS: Eight categories of adverse events were identified. Acute reduction in visual acuity attributable to either worsening of macular pathology or development of subretinal fluid, electroretinogram changes, dyschromatopsia, retinal tears and detachments, lens subluxation or phacodonesis, impaired pupillary reflex, and retinal vessel findings were reported in both the premarketing and postmarketing experiences. Ellipsoid zone (inner segment/outer segment) findings were only reported in the postmarketing experience. Rates of postmarketing reports were lower than in the premarketing data. Adverse events were generally transient, and characteristics of these adverse events were generally similar between the premarketing and postmarketing experience. CONCLUSION: Postmarket analyses are limited by significant underreporting, and in the case of ocriplasmin as a first in-class drug, they may not have captured safety events that have only more recently been identified. Nonetheless, postmarket analyses can identify the scope of potential safety events based on real-world experiences. Ocriplasmin administration should be guided by an appropriate and informed risk-benefit discussion with the patient. Ongoing active postmarket surveillance by all practitioners will continue to be critical to better understand this safety profile.


Asunto(s)
Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/etiología , Oftalmopatías/tratamiento farmacológico , Fibrinolisina/efectos adversos , Fibrinolíticos/efectos adversos , Fragmentos de Péptidos/efectos adversos , Vigilancia de Productos Comercializados , Enfermedades de la Retina/tratamiento farmacológico , Cuerpo Vítreo/efectos de los fármacos , Ensayos Clínicos como Asunto , Defectos de la Visión Cromática/inducido químicamente , Evaluación Preclínica de Medicamentos , Electrorretinografía/efectos de los fármacos , Fibrinolisina/uso terapéutico , Fibrinolíticos/uso terapéutico , Humanos , Inyecciones Intravítreas , Subluxación del Cristalino/inducido químicamente , Fragmentos de Péptidos/uso terapéutico , Células Fotorreceptoras de Vertebrados/efectos de los fármacos , Células Fotorreceptoras de Vertebrados/patología , Reflejo Pupilar/efectos de los fármacos , Desprendimiento de Retina/inducido químicamente , Perforaciones de la Retina/inducido químicamente , Estudios Retrospectivos , Adherencias Tisulares/tratamiento farmacológico , Agudeza Visual/efectos de los fármacos
3.
Arch Ophthalmol ; 130(7): 908-13, 2012 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-22776928

RESUMEN

OBJECTIVE: To assess the safety and efficacy of combined cataract extraction, posterior chamber intraocular lens placement, pars plana vitrectomy, fluocinolone acetonide intravitreal implant (Retisert), and Ahmed valves with pars plana tube (CPR-PT) in eyes with chronic, posterior, noninfectious uveitis. METHODS: Retrospective study of patients who underwent CPR-PT. Outcome measures included visual acuity, intraocular pressure, inflammation, and complications. RESULTS: Eight eyes were included, with a mean follow-up of 18 months. Mean visual acuity improved from 1.89 to 0.14 logMAR (Snellen, counting fingers at 2 ft [0.6 m]) to 20/30; P=.01). Mean intraocular pressure remained stable at 16 to 17 mm Hg (P=.35). The number of glaucoma medications per eye decreased from 2.9 to 0.25 (P=.01). Systemic prednisone therapy was discontinued in all patients by 9 months postoperatively. Inflammation was well controlled in all eyes. CONCLUSION: The CPR-PT procedure allows rapid visual rehabilitation without major short-term complications.


Asunto(s)
Extracción de Catarata , Implantes de Medicamentos , Fluocinolona Acetonida/administración & dosificación , Implantes de Drenaje de Glaucoma , Implantación de Lentes Intraoculares , Uveítis Posterior/complicaciones , Vitrectomía , Adulto , Anestesia Local , Antihipertensivos/administración & dosificación , Catarata/complicaciones , Catarata/terapia , Enfermedad Crónica , Femenino , Estudios de Seguimiento , Glaucoma/complicaciones , Glaucoma/cirugía , Humanos , Presión Intraocular/fisiología , Masculino , Persona de Mediana Edad , Segmento Posterior del Ojo , Complicaciones Posoperatorias , Estudios Retrospectivos , Esclerostomía , Técnicas de Sutura , Resultado del Tratamiento , Uveítis Posterior/tratamiento farmacológico , Agudeza Visual/fisiología , Cuerpo Vítreo/efectos de los fármacos
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