- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07609628
Effect of Silicon Oil on Retinal Electrical Functions Using Multifocal Electroretinogram (SO/RRD/mfERG)
Effect of Silicon Oil on Retinal Electrical Functions in Patients With Rhegmatogenous Retinal Detatchment Using Multifocal Electroretinogram .
Retinal detachment is one of the leading causes for permanent vision loss.Incidence of Rheugmatogenous Retinal Detachment (RRD) about 10.5 people per 100,000 population pars plana vitrectomy is the most popular and effective surgical options.
Tamponade agents as silicone oils are used to restore intraocular volume and apply surface tension to the detached retinal surface Silicone oil (SO) is a liquid containing polymerized siloxane with organic side chains. It has a high thermal stability, is hydrophobic, and chemically inert. The use of silicone oils as intraocular tamponades dates from 1962.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Retinal detachment is one of the leading causes for permanent vision loss.Incidence of Rheugmatogenous Retinal Detachment (RRD) about 10.5 people per 100,000 population pars plana vitrectomy is the most popular and effective surgical options.
Today, implanting silicone oil as a long-term tamponade is widespread and accepted. However, the oil can emulsify at the interface with its hydrophilic intraocular environment. Eyes treated with silicone oil that emulsifies can show up to 72% long-term complications, including corneal decompensation, band keratopathy, chronic elevations of intraocular pressure, opacification of the crystalline lens, retinopathies, and optic neuropathy.
Silicone oil floats in the vitreous cavity because the specific gravity is 0.97; its bubbles' surface tension may change after injection into the eye. Higher viscosity silicone oils have less emulsification.
In the vitreous cavity, buoyancy and gravity operate on an intraocular tamponade agent that presses against the retina as a downward force. Moreover, interfacial tension is the interaction between two immiscible chemicals, such silicone oil and aqueous humor.silicone oils have viscosities ranging from one thousand (MW 37 kDa) to five thousand (MW 65 kDa).
Multifocal electroretinography (mfERG) is an investigation that can simultaneously measure multiple electroretinographic responses at different retinal locations. mfERG allows topographic mapping of retinal function in the central 40-50° of the retina. The strength of mfERG lies in its ability to provide objective assessment of the central retinal function at different retinal areas within a short duration of time.The mfERG is taken under conditions of light adaptation in order to obtain an electrophysiological response from the cones.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Amany Nady Mohammed Mohammed, Resident
- Número de teléfono: +201151849593
- Correo electrónico: drmonmonnady92@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Amr Abdelrahman, professor
- Número de teléfono: +201093292792
Ubicaciones de estudio
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Minya Governorate
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Minya, Minya Governorate, Egipto, 61111
- Reclutamiento
- Faculty of Medicine
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Contacto:
- Amany Mohammed, MBBCH
- Número de teléfono: +201151849593
- Correo electrónico: drmonmonnady92@gmail.com
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Contacto:
- Amr A Abdelrahman, Lecturer
- Número de teléfono: +201093292792
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Investigador principal:
- Amany N Mohammed, MBBCH
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Patients with primary rhegmatogenous retinal detachment
Exclusion Criteria:
- Patients with history of previous intraocular surgery.
- Patients with combined traction-rhegmatogenous retinal detachment
- Patients with ocular disease as glaucoma ,degenerative myopia,age related macular degeneration
- Patients with poor fixation.
- Uncooperative patients.
- Patients with retinopathy.
- emulsified SO or complicated SO removal were excluded from this study
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Effect of Silicon Oil on Retinal Functions after Viterectomy
About the 50 patients suffering from Rhegmatogenous Retinal Detatchment.
All participants will undergo Viterectomy then the Retinal Functions will be evaluated by using Silicon oil tamponade recorded by Multi focal electroretinogram before and after the operation.
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to evaluat the effect of silicon oil on retinal function in the eyes that underwent Pars Plana Vitrectomy with Silicon oil tamponade for Rheugmatogenous Retinal Detachment.
mfERG responses were recorded before and after Silicon oil removal .
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Retinal Functions after vitrectomy
Periodo de tiempo: 1 Month to 3 Months
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Evaluation of the Function of the Eye Retina after Vitrectomy for all the participants
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1 Month to 3 Months
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Electroretinogram Examination after vitrectomy
Periodo de tiempo: 1 Month to 3 Months
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Electroretinogram examination which performed for all eyes after the vitrectomy as:When the light hits the eye, the photoreceptors (rods and cones) and other retinal cells generate small electrical impulses.
The Electroretinogram captures and graphs these impulses to evaluate if these cells are functioning normally or not.
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1 Month to 3 Months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Mahmoud Mohammed M. Genedy, Professor, Department of Ophthalmology, fuculty of medicine,Minia University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- Rhegmatogenous Retinal Detatch
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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