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

May 21, 2026 updated by: 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Amr Abdelrahman, professor
  • Phone Number: +201093292792

Study Locations

  • Egypt
    • Minya Governorate
      • Minya, Minya Governorate, Egypt, 61111
        • Recruiting
        • Faculty of medicine
        • Contact:
        • Contact:
          • Amr A Abdelrahman, Lecturer
          • Phone Number: +201093292792
        • Principal Investigator:
          • Amany N Mohammed, MBBCH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: 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 .
Other Names:
  • Silicon oil tamponade
  • Viterectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 Month to 3 Months
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.
1 Month to 3 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minia University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2026

Primary Completion (Estimated)

July 15, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

January 12, 2026

First Submitted That Met QC Criteria

May 21, 2026

First Posted (Actual)

May 27, 2026

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • Rhegmatogenous Retinal Detatch

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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