Back to resultsRepeatability of Electroretinogram and Visual Evoked Potential
Primary Purpose
Retinal Disease, Visual Impairment, Vision Disorders
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Electroretinogram (ERG)
Visual evoked potential (VEP)
Sponsored by
About this trial
This is an interventional diagnostic trial for Retinal Disease focused on measuring Electroretinogram, Visual evoked potential
Eligibility Criteria
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.
Sites / Locations
- Ahmed Abdelshafy TablRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Electroretinogram test (ERG)
Visual evoked potential test (VEP)
Arm Description
ERG test will be done for each subject twice and compare the results to assess repeatability of the test.
VEP test will be done for each subject twice and compare the results to assess repeatability of the test.
Outcomes
Primary Outcome Measures
Repeatability of ERG amplitude.
ERG amplitude measured in nano volt (nV).
Secondary Outcome Measures
Repeatability of ERG latency.
Latency of ERG measured by millisecond (msec).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05334875
Brief Title
Repeatability of Electroretinogram and Visual Evoked Potential
Official Title
Repeatability of Electroretinogram and Visual Evoked Potential in Clinical Practice
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
October 30, 2022 (Anticipated)
Study Completion Date
October 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
To assess repeatability of electroretinogram and visual evoked potential in clinical practice
Detailed Description
To assess repeatability of electroretinogram in evaluation of retinal function and visual evoked potential in evaluation of visual pathway in clinical practice.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Disease, Visual Impairment, Vision Disorders
Keywords
Electroretinogram, Visual evoked potential
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Electroretinogram test (ERG)
Arm Type
Active Comparator
Arm Description
ERG test will be done for each subject twice and compare the results to assess repeatability of the test.
Arm Title
Visual evoked potential test (VEP)
Arm Type
Active Comparator
Arm Description
VEP test will be done for each subject twice and compare the results to assess repeatability of the test.
Intervention Type
Diagnostic Test
Intervention Name(s)
Electroretinogram (ERG)
Intervention Description
Applying electrodes to assess retinal function
Intervention Type
Diagnostic Test
Intervention Name(s)
Visual evoked potential (VEP)
Intervention Description
Applying electrodes to assess visual pathway function
Primary Outcome Measure Information:
Title
Repeatability of ERG amplitude.
Description
ERG amplitude measured in nano volt (nV).
Time Frame
Changes from baseline measurements and at one week.
Secondary Outcome Measure Information:
Title
Repeatability of ERG latency.
Description
Latency of ERG measured by millisecond (msec).
Time Frame
Changes from baseline measurements and at one week.
Other Pre-specified Outcome Measures:
Title
Repeatability of VEP amplitude.
Description
VEP amplitude measured in nano volt (nV).
Time Frame
Changes from baseline measurements and at one week.
Title
Repeatability of VEP latency.
Description
Latency of VEP measured by millisecond (msec).
Time Frame
Changes from baseline measurements and at one week.
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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Abdelshafy, MD
Phone
01222328766
Email
ahmad4lg@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed A Abdelshafy, MD
Organizational Affiliation
Benha University
Official's Role
Study Chair
Facility Information:
Facility Name
Ahmed Abdelshafy Tabl
City
Banhā
State/Province
Benha
ZIP/Postal Code
13511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed A Tabl, MD
Phone
01222328766
Email
ahmad4lg@gmail.com
First Name & Middle Initial & Last Name & Degree
Marwa Abdelshafy, MD
Phone
01222328766
Email
ahmad4lg@gmail.com
First Name & Middle Initial & Last Name & Degree
marwa Abdelshafy, MD
12. IPD Sharing Statement
Learn more about this trial
Repeatability of Electroretinogram and Visual Evoked Potential
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