- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio 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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Amany Nady Mohammed Mohammed, Resident
- Número de telefone: +201151849593
- E-mail: drmonmonnady92@gmail.com
Estude backup de contato
- Nome: Amr Abdelrahman, professor
- Número de telefone: +201093292792
Locais de estudo
-
-
Minya Governorate
-
Minya, Minya Governorate, Egito, 61111
- Recrutamento
- Faculty of Medicine
-
Contato:
- Amany Mohammed, MBBCH
- Número de telefone: +201151849593
- E-mail: drmonmonnady92@gmail.com
-
Contato:
- Amr A Abdelrahman, Lecturer
- Número de telefone: +201093292792
-
Investigador principal:
- Amany N Mohammed, MBBCH
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Diagnóstico
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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.
|
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 .
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Retinal Functions after vitrectomy
Prazo: 1 Month to 3 Months
|
Evaluation of the Function of the Eye Retina after Vitrectomy for all the participants
|
1 Month to 3 Months
|
|
Electroretinogram Examination after vitrectomy
Prazo: 1 Month to 3 Months
|
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.
|
1 Month to 3 Months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Cadeira de estudo: Mahmoud Mohammed M. Genedy, Professor, Department of Ophthalmology, fuculty of medicine,Minia University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- Rhegmatogenous Retinal Detatch
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
produto fabricado e exportado dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .