NCT05323032

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 22, 2022

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 12, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

July 19, 2022

Status Verified

July 1, 2022

Enrollment Period

8 months

First QC Date

April 5, 2022

Last Update Submit

July 18, 2022

Conditions

Retinal DiseaseHealthy Population

Keywords

normalelectroretinogramdelta population

Outcome Measures

Primary Outcomes (2)

  • Amplitude of waves in nv/deg2

    Measurement of the amplitude of N1 and P1 waves.

    immediately after mf-ERG diagnostic test for each eye.

  • Latency of waves in msec.

    Measurement of the latency of N1 and P1 waves.

    immediately after mf-ERG diagnostic test for each eye.

Secondary Outcomes (1)

  • Difference between different age groups in mf-ERG readings.

    immediately after mf-ERG diagnostic test for each eye.

Study Arms (1)

Normal subjects

EXPERIMENTAL

Normal subjects at banha university that are seeking regular ophthalmic check-up.

Device: Multifocal electroretinogram (mf-ERG) by electroretinogram device

Interventions

Multifocal electroretinogram (mf-ERG) by electroretinogram deviceDEVICE

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.

Normal subjects

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Normal subjects seeking regular ophthalmic check-up at banha university hospital.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Abdelshafy Tabl

Banhā, Banha, 13511, Egypt

RECRUITING

MeSH Terms

Conditions

Retinal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • Ahmed A Tabl, MD

    Benha University

    STUDY CHAIR

Central Study Contacts

Ahmed A Tabl, MD

CONTACT

01222328766ahmad4lg@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Multifocal electroretinogram in normal population
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Ophthalmology

Study Record Dates

First Submitted

April 5, 2022

First Posted

April 12, 2022

Study Start

March 22, 2022

Primary Completion

November 15, 2022

Study Completion

December 30, 2022

Last Updated

July 19, 2022

Record last verified: 2022-07

Locations

EG(1)