Back to resultsMultifocal Electroretinogram in Normal Egyptian Population
Primary Purpose
Retinal Disease, Healthy Population
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Multifocal electroretinogram (mf-ERG) by electroretinogram device
Sponsored by
About this trial
This is an interventional diagnostic trial for Retinal Disease focused on measuring normal, electroretinogram, delta population
Eligibility Criteria
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.
Sites / Locations
- Ahmed Abdelshafy TablRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Normal subjects
Arm Description
Normal subjects at banha university that are seeking regular ophthalmic check-up.
Outcomes
Primary Outcome Measures
Amplitude of waves in nv/deg2
Measurement of the amplitude of N1 and P1 waves.
Latency of waves in msec.
Measurement of the latency of N1 and P1 waves.
Secondary Outcome Measures
Difference between different age groups in mf-ERG readings.
Statistical analysis for mf-ERG amplitude and latency in different age groups.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05323032
Brief Title
Multifocal Electroretinogram in Normal Egyptian Population
Official Title
Normal Multifocal Electroretinogram in Egyptian Population.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 22, 2022 (Actual)
Primary Completion Date
November 15, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benha University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Studying normal subjects to create unique normal database for multifocal electroretinogram (mf-ERG) in specific population.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Disease, Healthy Population
Keywords
normal, electroretinogram, delta population
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Multifocal electroretinogram in normal population
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Normal subjects
Arm Type
Experimental
Arm Description
Normal subjects at banha university that are seeking regular ophthalmic check-up.
Intervention Type
Device
Intervention Name(s)
Multifocal electroretinogram (mf-ERG) by electroretinogram device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Amplitude of waves in nv/deg2
Description
Measurement of the amplitude of N1 and P1 waves.
Time Frame
immediately after mf-ERG diagnostic test for each eye.
Title
Latency of waves in msec.
Description
Measurement of the latency of N1 and P1 waves.
Time Frame
immediately after mf-ERG diagnostic test for each eye.
Secondary Outcome Measure Information:
Title
Difference between different age groups in mf-ERG readings.
Description
Statistical analysis for mf-ERG amplitude and latency in different age groups.
Time Frame
immediately after mf-ERG diagnostic test for each eye.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed A Tabl, MD
Phone
01222328766
Email
ahmad4lg@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed A Tabl, MD
Organizational Affiliation
Benha University
Official's Role
Study Chair
Facility Information:
Facility Name
Ahmed Abdelshafy Tabl
City
Banhā
State/Province
Banha
ZIP/Postal Code
13511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed A Tabl
Phone
01222328766
Email
ahmad4lg@gmail.com
First Name & Middle Initial & Last Name & Degree
marwa Abdelshafy, MD
First Name & Middle Initial & Last Name & Degree
Ahmed A Tabl, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Multifocal Electroretinogram in Normal Egyptian Population
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