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NCT Number: NCT07609628

Effect of Silicon Oil on Retinal Electrical Functions 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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of medicine

Minya, Minya Governorate, 61111, Egypt

Location status: Recruiting

Location contact

Amany Mohammed, MBBCH

CONTACT

[email protected]

+201151849593

Amany N Mohammed, MBBCH

PRINCIPAL_INVESTIGATOR

Amr A Abdelrahman, Lecturer

CONTACT

+201093292792

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multi focal electroretinogram

Device

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 .

Other names: Silicon oil tamponade, Viterectomy

Primary outcomes

  1. Retinal Functions after vitrectomy

    Time frame: 1 Month to 3 Months

    Evaluation of the Function of the Eye Retina after Vitrectomy for all the participants

  2. Electroretinogram Examination after vitrectomy

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Amany Nady Mohammed Mohammed, Resident

CONTACT

[email protected]

+201151849593

Amr Abdelrahman, professor

CONTACT

+201093292792

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study title

Effect of Silicon Oil on Retinal Electrical Functions in Patients With Rhegmatogenous Retinal Detatchment Using Multifocal Electroretinogram .

Acronym: SO/RRD/mfERG

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 27, 2026
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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