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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Amany Nady Mohammed Mohammed, Resident
- Telefonnummer: +201151849593
- E-post: drmonmonnady92@gmail.com
Studera Kontakt Backup
- Namn: Amr Abdelrahman, professor
- Telefonnummer: +201093292792
Studieorter
-
-
Minya Governorate
-
Minya, Minya Governorate, Egypten, 61111
- Rekrytering
- Faculty of Medicine
-
Kontakt:
- Amany Mohammed, MBBCH
- Telefonnummer: +201151849593
- E-post: drmonmonnady92@gmail.com
-
Kontakt:
- Amr A Abdelrahman, Lecturer
- Telefonnummer: +201093292792
-
Huvudutredare:
- Amany N Mohammed, MBBCH
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Diagnostisk
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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 .
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Retinal Functions after vitrectomy
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studiestol: Mahmoud Mohammed M. Genedy, Professor, Department of Ophthalmology, fuculty of medicine,Minia University
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- Rhegmatogenous Retinal Detatch
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
produkt tillverkad i och exporterad från U.S.A.
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .