Recruiting NCT07609628

Effect of Silicon Oil on Retinal Electrical Functions Using Multifocal Electroretinogram

No phase Interventional Rhegmatogenous Retinal Detachment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Multi focal electroretinogram.
Who it may be relevant to: Registry conditions: Rhegmatogenous Retinal Detachment. Basic parameters: 18 years — 70 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Egypt
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Official title

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

Overview

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.

Detailed description

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.

Interventions

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 .

Primary outcome measures

Retinal Functions after vitrectomy [Time frame: 1 Month to 3 Months]
Electroretinogram Examination after vitrectomy [Time frame: 1 Month to 3 Months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: N/A
Model: Single group
Masking: Open label
Primary purpose: Diagnostic

Study locations

Egypt · 1 center

Faculty of medicine — Minya

Identifiers

NCT: NCT07609628 · Rhegmatogenous Retinal Detatch

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗