Repeatability of Electroretinogram and Visual Evoked Potential

• Sponsor: Benha University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05334875
• Collaborator: (none)
• Enrollment: 250
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 7
• Patients Per Site Per Month: 35.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Retinal Disease; Visual Impairment; Vision Disorders	Diagnostic Test: Electroretinogram (ERG); Diagnostic Test: Visual evoked potential (VEP)	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 250 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Repeatability of Electroretinogram and Visual Evoked Potential in Clinical Practice
• Actual Study Start Date: Apr 1, 2022
• Anticipated Primary Completion Date: Oct 30, 2022
• Anticipated Study Completion Date: Oct 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Repeatability of ERG amplitude. [Changes from baseline measurements and at one week.]

   ERG amplitude measured in nano volt (nV).

Secondary Outcome Measures

1. Repeatability of ERG latency. [Changes from baseline measurements and at one week.]

   Latency of ERG measured by millisecond (msec).

Other Outcome Measures

1. Repeatability of VEP amplitude. [Changes from baseline measurements and at one week.]

   VEP amplitude measured in nano volt (nV).

2. Repeatability of VEP latency. [Changes from baseline measurements and at one week.]

   Latency of VEP measured by millisecond (msec).

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 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.

Contacts and Locations

Locations

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

Sponsors and Collaborators

• Benha University

Investigators

• Study Chair: Ahmed A Abdelshafy, 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: NCT05334875
• Other Study ID Numbers: RC 8-22
• First Posted: Apr 19, 2022
• Last Update Posted: Apr 19, 2022
• Last Verified: Apr 1, 2022

• 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: Electroretinogram; Visual evoked potential
• Additional relevant MeSH terms: Vision Disorders; Vision, Low; Retinal Diseases

Study Results

No Results Posted as of Apr 19, 2022