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Effect of Silicon Oil on Retinal Electrical Functions Using Multifocal Electroretinogram (SO/RRD/mfERG)

21. maj 2026 opdateret af: Amany Nady Mohammed, Minia University

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

50

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

  • Navn: Amr Abdelrahman, professor
  • Telefonnummer: +201093292792

Studiesteder

  • Egypten
    • Minya Governorate
      • Minya, Minya Governorate, Egypten, 61111
        • Rekruttering
        • Faculty of medicine
        • Kontakt:
        • Kontakt:
          • Amr A Abdelrahman, Lecturer
          • Telefonnummer: +201093292792
        • Ledende efterforsker:
          • Amany N Mohammed, MBBCH

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Enhed: Multi focal electroretinogram
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 .
Andre navne:
  • Silicon oil tamponade
  • Viterectomy

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Retinal Functions after vitrectomy
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Minia University

Efterforskere

  • Studiestol: Mahmoud Mohammed M. Genedy, Professor, Department of Ophthalmology, fuculty of medicine,Minia University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. februar 2026

Primær færdiggørelse (Anslået)

15. juli 2026

Studieafslutning (Anslået)

1. august 2026

Datoer for studieregistrering

Først indsendt

12. januar 2026

Først indsendt, der opfyldte QC-kriterier

21. maj 2026

Først opslået (Faktiske)

27. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. maj 2026

Sidst verificeret

1. januar 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • Rhegmatogenous Retinal Detatch

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Rhegmatogen nethindeløsning

Kliniske forsøg med Multi focal electroretinogram

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