Multifocal Electroretinogram in Normal Egyptian Population

July 18, 2022 updated by: Ahmed Abdelshafy, Benha University

Normal Multifocal Electroretinogram in Egyptian Population.

Studying normal subjects to create unique normal database for multifocal electroretinogram (mf-ERG) in specific population.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Normal parameters for electroretinogram (ERG) is important in studying specific population, studying normal subjects is important to create specific normal database for each population. This will help in accurate differentiation for various ocular diseases and in research trials.

Study Type

Interventional

Enrollment (Anticipated)

100

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
    • Banha
      • Banhā, Banha, Egypt, 13511
        • Recruiting
        • Ahmed Abdelshafy Tabl
        • Contact:
        • Principal Investigator:
          • marwa Abdelshafy, MD
        • Sub-Investigator:
          • Ahmed A Tabl, 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

14 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Normal subjects seeking regular ophthalmic check-up at banha university hospital.

Exclusion Criteria:

  • Any retinal diseases that may affects mf-ERG waves.
  • Subjects with best corrected visual acuity less than 0.7 in decimal form at time of examination.
  • Refractive errors more than 0.5 diopter as measured by autorefractometer.

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: Normal subjects
Normal subjects at banha university that are seeking regular ophthalmic check-up.
Device: Multifocal electroretinogram (mf-ERG) by electroretinogram device
Measurement of mf-ERG parameters with 61 stimulus elements to asses amplitude of waves in nano volt/degree square (nv/deg2) and latency in millisecond (msec) as measured by electroretinogram device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amplitude of waves in nv/deg2
Time Frame: immediately after mf-ERG diagnostic test for each eye.
Measurement of the amplitude of N1 and P1 waves.
immediately after mf-ERG diagnostic test for each eye.
Latency of waves in msec.
Time Frame: immediately after mf-ERG diagnostic test for each eye.
Measurement of the latency of N1 and P1 waves.
immediately after mf-ERG diagnostic test for each eye.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference between different age groups in mf-ERG readings.
Time Frame: immediately after mf-ERG diagnostic test for each eye.
Statistical analysis for mf-ERG amplitude and latency in different age groups.
immediately after mf-ERG diagnostic test for each eye.

Collaborators and Investigators

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

Sponsor

Benha University

Investigators

  • Study Chair: Ahmed A Tabl, 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)

March 22, 2022

Primary Completion (Anticipated)

November 15, 2022

Study Completion (Anticipated)

December 30, 2022

Study Registration Dates

First Submitted

April 5, 2022

First Submitted That Met QC Criteria

April 5, 2022

First Posted (Actual)

April 12, 2022

Study Record Updates

Last Update Posted (Actual)

July 19, 2022

Last Update Submitted That Met QC Criteria

July 18, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC 5-22

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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