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Multifocal Electroretinogram in Normal Egyptian Population

Sponsor
Benha University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05323032
Collaborator
(none)
100
Enrollment
1
Location
1
Arm
9.3
Anticipated Duration (Months)
10.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Multifocal electroretinogram (mf-ERG) by electroretinogram device
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Multifocal electroretinogram in normal populationMultifocal electroretinogram in normal population
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Normal Multifocal Electroretinogram in Egyptian Population.
Actual Study Start Date :
Mar 22, 2022
Anticipated Primary Completion Date :
Nov 15, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Amplitude of waves in nv/deg2 [immediately after mf-ERG diagnostic test for each eye.]

    Measurement of the amplitude of N1 and P1 waves.

  2. Latency of waves in msec. [immediately after mf-ERG diagnostic test for each eye.]

    Measurement of the latency of N1 and P1 waves.

Secondary Outcome Measures

  1. Difference between different age groups in mf-ERG readings. [immediately after mf-ERG diagnostic test for each eye.]

    Statistical analysis for mf-ERG amplitude and latency in different age groups.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ahmed Abdelshafy Tabl Banhā Banha Egypt 13511

Sponsors and Collaborators

  • Benha University

Investigators

  • Study Chair: Ahmed A Tabl, MD, Benha University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ahmed Abdelshafy, Lecturer of Ophthalmology, Benha University
ClinicalTrials.gov Identifier:
NCT05323032
Other Study ID Numbers:
  • RC 5-22
First Posted:
Apr 12, 2022
Last Update Posted:
Jul 19, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ahmed Abdelshafy, Lecturer of Ophthalmology, Benha University
normal
electroretinogram
delta population
Additional relevant MeSH terms:
Retinal Diseases

Study Results

No Results Posted as of Jul 19, 2022