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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05323032
Other study ID # RC 5-22
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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.
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