Repeatability of Electroretinogram and Visual Evoked Potential

NCT05334875 | Unknown DMC

• 1 other identifier: RC 8-22
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Retinal Disease; Visual Impairment; Vision Disorders

Keywords

Electroretinogram; Visual evoked potential

Outcome Measures

Primary Outcomes (1)

• Repeatability of ERG amplitude.

  ERG amplitude measured in nano volt (nV).

  Changes from baseline measurements and at one week.

Secondary Outcomes (1)

• Repeatability of ERG latency.

  Changes from baseline measurements and at one week.

Other Outcomes (2)

• Repeatability of VEP amplitude.

  Changes from baseline measurements and at one week.

• Repeatability of VEP latency.

  Changes from baseline measurements and at one week.

Study Arms (2)

Electroretinogram test (ERG)

ACTIVE COMPARATOR

ERG test will be done for each subject twice and compare the results to assess repeatability of the test.

Diagnostic Test: Electroretinogram (ERG)

Visual evoked potential test (VEP)

ACTIVE COMPARATOR

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)

Interventions

Electroretinogram (ERG) DIAGNOSTIC_TEST

Applying electrodes to assess retinal function

Electroretinogram test (ERG)

Visual evoked potential (VEP) DIAGNOSTIC_TEST

Applying electrodes to assess visual pathway function

Visual evoked potential test (VEP)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Normal subjects visit banha university hospital seeking regular checkup and subjects asked for ERG and VEP as a pre-occupational examination.

You may not qualify if:

• Patients previously diagnosed with any retinal disease or visual pathway disease that may affect ERG and VEP tests.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Ahmed Abdelshafy Tabl

Banhā, Benha, 13511, Egypt

RECRUITING

MeSH Terms

Conditions

Retinal Diseases; Vision Disorders

Interventions

Electroretinography; Evoked Potentials, Visual

Condition Hierarchy (Ancestors)

Eye Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Ophthalmological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Evoked Potentials; Cortical Excitability; Electrophysiological Phenomena; Physiological Phenomena; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Ocular Physiological Phenomena

Study Officials

• Ahmed A Abdelshafy, MD

  Benha University

  STUDY CHAIR

Central Study Contacts

Ahmed Abdelshafy, MD

CONTACT

01222328766; ahmad4lg@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Ophthalmology

Study Record Dates

• First Submitted: April 7, 2022
• First Posted: April 19, 2022
• Study Start: April 1, 2022
• Primary Completion: October 30, 2022
• Study Completion: October 30, 2022
• Last Updated: April 19, 2022

Record last verified: 2022-04

Locations

EG (1)