CIRCATThe Effect of Cataract on Photoentrainment of the Circadian Rhythm in Humans
Conventional Intra Ocular Lens (IOL)
+ Yellow Intra Ocular Lens (IOL)
Enfermedades Oculares
+ Enfermedades del Cristalino
+ Catarata
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de febrero de 2011
Fecha en la que se inscribió al primer participante.Cataract is globally the most common cause of blindness and in Denmark the operation with - 50.000 treatments per year - is the most common eye operation. The cause of cataract is growth and denaturation of the lens proteins. This leads to an increased absorption of blue light and increased light scatter. This may affect newly discovered cells in the retina that are involved in the regulation of the circadian rhythm. When the internal circadian rhythm is not synchronized with the external day and night a phase-shift occurs. Most people know of this discomfort as jet-lag, but the consequences may be much more severe such as heighten risk of cancer and cardiovascular disease. The goal of this project is to study how the circadian regulating cells of the retina is affected by cataract and by the operation. Cataract patients are studied before and after the operation with questionnaires, hormone and activity measurements and with a specialized pupil measurement that measures the indirect response of the circadian regulating cells to blue light. Results from this study aim to shed light on the regulatory mechanisms of the eye on the circadian rhythm and how these are affected by cataract. Furthermore, choice of intraocular lens is evaluated. This may have impact on clinical practise especially with regard to choice of intraocular lens and widened indications for cataract surgery.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 76 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 18 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria: Age related/senile bilateral cataract Eligible for phaco-emulsification on both eyes Exclusion Criteria: Known eye disease other than cataract. Known systemic disease, which may affect the retina (untreated hypertension, DM etc.) Known systemic disease, which may affect the lens. Known psychiatric disease. Known sleep or circadian rhythm disorder, not caused by lowered blue light transmission by the lens. Per- and post operative complications Use of drugs that may affect the sleep. For a subpopulation also: Poor cooperation. Severe refraction abnormalities. Previous eye surgery Nystagmus Congenital or acquired abnormalities of: eye lids and eye area, cornea or iris. Use of medicine that may affect the pupillary response. Use of drugs that may affect the pupillary response.
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.2 grupos de intervención están designados en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
Comparador ActivoGrupo II
ExperimentalObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación
Glostrup University Hospital
Glostrup Municipality, DenmarkAbrir Glostrup University Hospital en Google Maps