Multifocal Electroretinography Before and After Silicone Oil Removal

October 9, 2021 updated by: Mohamed Abdel Hamid, Minia University
This is a prospective observational study to investigate the changes in multifocal electroretinogram signal before and after silicone oil removal in silicone-filled eyes.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

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

Study Locations

  • Egypt
      • Minya, Egypt, 61111

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

A total of 30 patients will be recruited. We will include patients 18 years of age or older who underwent PPV for the repair of rhegmatogenous retinal detachment (RRD) and received silicone oil as an intraocular tamponade. Patients will be excluded if they have a significant corneal opacity, uncontrolled intraocular pressure, a confounding macular pathology or optic nerve pathology or if silicone oil has been in the eye for longer than 6 months.

Description

Inclusion Criteria:

  • Patients 18 years of age or older who underwent pars plana vitrectomy for the repair of rhegmatogenous retinal detachment (RRD) and received silicone oil as an intraocular tamponade.

Exclusion Criteria:

  • Patients will be excluded if they have a significant corneal opacity, uncontrolled intraocular pressure, a confounding macular pathology or optic nerve pathology or if silicone oil has been in the eye for longer than 6 months.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Silicone-filled eyes
Diagnostic test: Multifocal electroretinogram
A device that records electric potentials generated by the retinal photoreceptors and neural elements in a multifocal fashion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Amplitude
Time Frame: Preoperative and 1 month postoperative recordings
Change in amplitudes of P1 and N1 waves before and after silicone oil removal
Preoperative and 1 month postoperative recordings

Collaborators and Investigators

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

Sponsor

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)

October 1, 2021

Primary Completion (ANTICIPATED)

January 31, 2022

Study Completion (ANTICIPATED)

March 31, 2022

Study Registration Dates

First Submitted

October 9, 2021

First Submitted That Met QC Criteria

October 9, 2021

First Posted (ACTUAL)

October 21, 2021

Study Record Updates

Last Update Posted (ACTUAL)

October 21, 2021

Last Update Submitted That Met QC Criteria

October 9, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 34:3/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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