Retinal DiseaseNCT05334875
Repeatability of Electroretinogram and Visual Evoked Potential
A study testing Electroretinogram (ERG) and Visual evoked potential (VEP) in people with Retinal Disease and Visual Impairment, run by Benha University at 1 site in Egypt.
Trial summary
To assess repeatability of electroretinogram and visual evoked potential in clinical practice 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, Visual Impairment, Vision Disorders
- What is being tested?
- Electroretinogram (ERG) and Visual evoked potential (VEP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2022to 30 Oct 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 visit banha university hospital seeking regular checkup and subjects asked for ERG and VEP as a pre-occupational examination.
Who cannot join
- Patients previously diagnosed with any retinal disease or visual pathway disease that may affect ERG and VEP tests.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ahmed Abdelshafy Tabl
Banhā, Benha, 13511
Ahmed A Tabl, MD, 01222328766, ahmad4lg@gmail.com
Marwa Abdelshafy, MD, 01222328766, ahmad4lg@gmail.com
About this study
Official title: Repeatability of Electroretinogram and Visual Evoked Potential in Clinical Practice
To assess repeatability of electroretinogram and visual evoked potential in clinical practice
Read the detailed description
To assess repeatability of electroretinogram in evaluation of retinal function and visual evoked potential in evaluation of visual pathway in clinical practice.
- Conditions
- Retinal Disease, Visual Impairment, Vision Disorders
- Being tested
- Electroretinogram (ERG), Visual evoked potential (VEP)
- Keywords
- Electroretinogram, Visual evoked potential
- Medical subject headings
- Retinal Diseases, Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroretinogram (ERG)Diagnostic test
Applying electrodes to assess retinal function
Visual evoked potential (VEP)Diagnostic test
Applying electrodes to assess visual pathway function
| Study group | Role | What they receive |
|---|---|---|
| Electroretinogram test (ERG) | Active comparator | ERG test will be done for each subject twice and compare the results to assess repeatability of the test. Receives: 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. Receives: Diagnostic Test: Visual evoked potential (VEP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Repeatability of ERG amplitude.
ERG amplitude measured in nano volt (nV).
Measured: Changes from baseline measurements and at one week.
Secondary outcomes (1)
Repeatability of ERG latency.
Latency of ERG measured by millisecond (msec).
Measured: Changes from baseline measurements and at one week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start1 Apr 2022
- Primary completion30 Oct 2022 (estimated)
- Study completion30 Oct 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 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 Abdelshafy, MD, Study chair, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05334875
- Sponsor's protocol ID
- RC 8-22
- Status last verified
- Apr 2022
- First submitted
- 7 Apr 2022
- Last updated
- 19 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeatability of Electroretinogram and Visual Evoked Potential in Clinical Practice
- ClinicalTrials.gov ID
- NCT05334875
- Acronym / sponsor ID
- RC 8-22
- Conditions
- Retinal Disease, Visual Impairment, Vision Disorders
- Keywords
- Electroretinogram, Visual evoked potential
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Oct 2022 (estimated)
- Study completion
- 30 Oct 2022 (estimated)
- First posted
- 19 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.
To assess repeatability of electroretinogram and visual evoked potential in clinical practice
Detailed description
To assess repeatability of electroretinogram in evaluation of retinal function and visual evoked potential in evaluation of visual pathway in clinical practice.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electroretinogram test (ERG) | Active comparator | Diagnostic Test: Electroretinogram (ERG)ERG test will be done for each subject twice and compare the results to assess repeatability of the test. |
| Visual evoked potential test (VEP) | Active comparator | Diagnostic Test: Visual evoked potential (VEP)VEP test will be done for each subject twice and compare the results to assess repeatability of the test. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Normal subjects visit banha university hospital seeking regular checkup and subjects asked for ERG and VEP as a pre-occupational examination.
Key exclusion criteria (1 listed)
- Patients previously diagnosed with any retinal disease or visual pathway disease that may affect ERG and VEP tests.
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 |
|---|---|---|
| Electroretinogram (ERG)Applying electrodes to assess retinal function | Diagnostic test | Electroretinogram test (ERG) |
| Visual evoked potential (VEP)Applying electrodes to assess visual pathway function | Diagnostic test | Visual evoked potential test (VEP) |
Primary outcome
Repeatability of ERG amplitude.
Time frame: Changes from baseline measurements and at one week.
ERG amplitude measured in nano volt (nV).
1 secondary outcome
Repeatability of ERG latency.
Time frame: Changes from baseline measurements and at one week.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2022.
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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 Abdelshafy, 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 Electroretinogram (ERG) and Visual evoked potential (VEP) in people with Retinal Disease and Visual Impairment, 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 1 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 Apr 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 Abdelshafy, 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?
Repeatability of ERG amplitude. (time frame: Changes from baseline measurements and at one week.). 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 Apr 2022.