Multifocal Electroretinogram in Normal Egyptian Population

Retinal Disease Clinical Trial

Official title:

Normal Multifocal Electroretinogram in Egyptian Population.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05323032
• Other study ID #: RC 5-22
• Status: Recruiting
• Phase: N/A
• Start date: March 22, 2022
• Est. completion date: December 30, 2022

Study information

• Verified date: July 2022
• Source: Benha University
• Contact: Ahmed A Tabl, MD
• Phone: 01222328766
• Email: ahmad4lg[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 30, 2022
• Est. primary completion date: November 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Population
• Retinal Disease
• Retinal Diseases

Intervention

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.

Locations

Country	Name	City	State
Egypt	Ahmed Abdelshafy Tabl	Banha	Banha

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amplitude of waves in nv/deg2	Measurement of the amplitude of N1 and P1 waves.	immediately after mf-ERG diagnostic test for each eye.
Primary	Latency of waves in msec.	Measurement of the latency of N1 and P1 waves.	immediately after mf-ERG diagnostic test for each eye.
Secondary	Difference between different age groups in mf-ERG readings.	Statistical analysis for mf-ERG amplitude and latency in different age groups.	immediately after mf-ERG diagnostic test for each eye.