Retinal DiseaseNCT05323032
Multifocal Electroretinogram in Normal Egyptian Population
A study testing Multifocal electroretinogram (mf-ERG) by electroretinogram device in people with Retinal Disease and Healthy Population, run by Benha University at 1 site in Egypt.
Trial summary
Studying normal subjects to create unique normal database for multifocal electroretinogram (mf-ERG) in specific population. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Retinal Disease, Healthy Population
- What is being tested?
- Multifocal electroretinogram (mf-ERG) by electroretinogram device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Mar 2022to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal subjects seeking regular ophthalmic check-up at banha university hospital.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ahmed Abdelshafy Tabl
Banhā, Banha, 13511
Ahmed A Tabl, 01222328766, ahmad4lg@gmail.com
marwa Abdelshafy, MD
About this study
Official title: Normal Multifocal Electroretinogram in Egyptian Population.
Studying normal subjects to create unique normal database for multifocal electroretinogram (mf-ERG) in specific population.
Read the detailed 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.
- Conditions
- Retinal Disease, Healthy Population
- Being tested
- Multifocal electroretinogram (mf-ERG) by electroretinogram device
- Keywords
- normal, electroretinogram, delta population
- Medical subject headings
- Retinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Normal subjects | Experimental | Normal subjects at banha university that are seeking regular ophthalmic check-up. Receives: Device: Multifocal electroretinogram (mf-ERG) by electroretinogram device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amplitude of waves in nv/deg2
Measurement of the amplitude of N1 and P1 waves.
Measured: immediately after mf-ERG diagnostic test for each eye.
Latency of waves in msec.
Measurement of the latency of N1 and P1 waves.
Measured: immediately after mf-ERG diagnostic test for each eye.
Secondary outcomes (1)
Difference between different age groups in mf-ERG readings.
Statistical analysis for mf-ERG amplitude and latency in different age groups.
Measured: immediately after mf-ERG diagnostic test for each eye.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start22 Mar 2022
- Primary completion15 Nov 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Multifocal electroretinogram in normal population
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdelshafy, Benha University
- Investigators
- Ahmed A Tabl, MD, Study chair, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05323032
- Sponsor's protocol ID
- RC 5-22
- Status last verified
- Jul 2022
- First submitted
- 5 Apr 2022
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normal Multifocal Electroretinogram in Egyptian Population.
- ClinicalTrials.gov ID
- NCT05323032
- Acronym / sponsor ID
- RC 5-22
- Conditions
- Retinal Disease, Healthy Population
- Keywords
- normal, electroretinogram, delta population
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 22 Mar 2022 (actual)
- Primary completion
- 15 Nov 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 12 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Studying normal subjects to create unique normal database for multifocal electroretinogram (mf-ERG) in specific population.
Detailed 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multifocal electroretinogram in normal population
| Arm | Type | Receives |
|---|---|---|
| Normal subjects | Experimental | Device: Multifocal electroretinogram (mf-ERG) by electroretinogram deviceNormal subjects at banha university that are seeking regular ophthalmic check-up. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Normal subjects seeking regular ophthalmic check-up at banha university hospital.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multifocal electroretinogram (mf-ERG) by electroretinogram deviceMeasurement 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. | Device | Normal subjects |
Primary outcome
Amplitude of waves in nv/deg2
Time frame: immediately after mf-ERG diagnostic test for each eye.
Measurement of the amplitude of N1 and P1 waves.
Latency of waves in msec.
Time frame: immediately after mf-ERG diagnostic test for each eye.
Measurement of the latency of N1 and P1 waves.
1 secondary outcome
Difference between different age groups in mf-ERG readings.
Time frame: immediately after mf-ERG diagnostic test for each eye.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed A Tabl, MD study chair
Benha University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multifocal electroretinogram (mf-ERG) by electroretinogram device in people with Retinal Disease and Healthy Population, run by Benha University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed A Tabl, MD (01222328766, ahmad4lg@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amplitude of waves in nv/deg2 (time frame: immediately after mf-ERG diagnostic test for each eye.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2022.