Repeatability of Electroretinogram and Visual Evoked Potential

April 13, 2022 updated by: Ahmed Abdelshafy, Benha University

Repeatability of Electroretinogram and Visual Evoked Potential in Clinical Practice

To assess repeatability of electroretinogram and visual evoked potential in clinical practice

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

To assess repeatability of electroretinogram in evaluation of retinal function and visual evoked potential in evaluation of visual pathway in clinical practice.

Study Type

Interventional

Enrollment (Anticipated)

250

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 Locations

  • Egypt
    • Benha
      • Banhā, Benha, Egypt, 13511
        • Recruiting
        • Ahmed Abdelshafy Tabl
        • Contact:
        • Contact:
        • Principal Investigator:
          • marwa Abdelshafy, MD

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 to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Normal subjects visit banha university hospital seeking regular checkup and subjects asked for ERG and VEP as a pre-occupational examination.

Exclusion Criteria:

  • Patients previously diagnosed with any retinal disease or visual pathway disease that may affect ERG and VEP tests.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Electroretinogram test (ERG)
ERG test will be done for each subject twice and compare the results to assess repeatability of the test.
Diagnostic test: Electroretinogram (ERG)
Applying electrodes to assess retinal function
Active Comparator: Visual evoked potential test (VEP)
VEP test will be done for each subject twice and compare the results to assess repeatability of the test.
Diagnostic test: Visual evoked potential (VEP)
Applying electrodes to assess visual pathway function

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Repeatability of ERG amplitude.
Time Frame: Changes from baseline measurements and at one week.
ERG amplitude measured in nano volt (nV).
Changes from baseline measurements and at one week.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Repeatability of ERG latency.
Time Frame: Changes from baseline measurements and at one week.
Latency of ERG measured by millisecond (msec).
Changes from baseline measurements and at one week.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Repeatability of VEP amplitude.
Time Frame: Changes from baseline measurements and at one week.
VEP amplitude measured in nano volt (nV).
Changes from baseline measurements and at one week.
Repeatability of VEP latency.
Time Frame: Changes from baseline measurements and at one week.
Latency of VEP measured by millisecond (msec).
Changes from baseline measurements and at one week.

Collaborators and Investigators

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

Sponsor

Benha University

Investigators

  • Study Chair: Ahmed A Abdelshafy, MD, Benha 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)

April 1, 2022

Primary Completion (Anticipated)

October 30, 2022

Study Completion (Anticipated)

October 30, 2022

Study Registration Dates

First Submitted

April 7, 2022

First Submitted That Met QC Criteria

April 13, 2022

First Posted (Actual)

April 19, 2022

Study Record Updates

Last Update Posted (Actual)

April 19, 2022

Last Update Submitted That Met QC Criteria

April 13, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC 8-22

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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