Dark-adapted ERGSHERGNCT03275441
Electroretinography: Investigation of a Protocol Change
An observational study of Dark-adapted ERG, run by NHS Greater Glasgow and Clyde.
Trial summary
The study evaluates whether an eye test called an electroretinogram (ERG) can be shortened and still produce the same diagnostic results. The results of this study may allow test times to be reduced which will have benefits such as improved patient compliance during shorter testing and increased clinic efficiency. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dark-adapted ERG
- What is being tested?
- Electroretinography
- How many people
- 262 participants
- Where
- No sites listed yet
- Study dates
- Oct 2017to Feb 2018
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patient population attending hospital for routine clinical electroretinography.
Who may be able to join
- Patients referred to the adult visual electrophysiology service regardless of clinical condition, and who require dark-adapted electroretinography as part of their appointment
- Male or female
- All ethnicities
Who cannot join
- Patients less than 18 years old
- Patients who might have difficulties understanding the participant information provided (for example, those patients requiring a translator, or who have learning difficulties)
- Patients with photosensitive epilepsy
- Patients appointed for clinical testing urgently, or via telephone, who will not have had an opportunity to receive and review the participant information sheet ahead of the clinical appointment.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Investigation of a Protocol Change (Shorter Dark-adaptation) on the Electroretinogram (ERG) in an Adult Patient Population (SHERG)
The study evaluates whether an eye test called an electroretinogram (ERG) can be shortened and still produce the same diagnostic results. The results of this study may allow test times to be reduced which will have benefits such as improved patient compliance during shorter testing and increased clinic efficiency.
Read the detailed description
A full-field electroretinogram (ERG) is a standardised eye test undertaken in specialist hospital clinics. ERGs are useful for diagnosing and monitoring retinal diseases. The retina is stimulated by showing patients flashes of light and the resulting electrical response from the eye is recorded using delicate electrodes that touch the surface of the eye. For the first section of the test, patient's eyes are allowed to adjust to the dark to ensure the parts of the retina responsible for seeing in dimly-lit conditions are being tested.
The international ERG Standard says patients must sit in the dark for 20 minutes. The investigators have evidence to suggest the test may be equally useful after only 10 minutes in the dark. The investigators plan to compare ERGs recorded from patients who have spent only 10 minutes in the dark with ERGs recorded from the same patients after the full 20 minutes in the dark. If the difference is suitably small, as found in a preliminary study of healthy individuals, it could be justifiable to shorten the routine patient protocol.
Subjects for this study will be recruited from the adult population routinely attending for an outpatient ERG test. During their routine ERG test, 10 minutes into the 20 minute wait in the dark, the investigators propose recording an additional, identical set of ERG tests. This will not add extra time to the clinical test.
Participants will not need any follow-up for the research study. The study requires 262 patients to test the hypothesis, and the investigators estimate this will take about 5-6 months.
- Conditions
- Dark-adapted ERG
- Being tested
- Electroretinography
- Keywords
- electroretinogram, ERG, dark-adaptation, ophthalmology, electrophysiology, ISCEV, electroretinography, scotopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroretinographyDiagnostic test
An additional electroretinogram performed after 10 minutes of dark adaptation.
| Study group | Role | What they receive |
|---|---|---|
| Adult patients | Adult patients attending hospital for clinical visual electrophysiology. Receives: Diagnostic Test: Electroretinography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of classification for ERG following 10 minute dark adaptation
The rate of classification (normal vs abnormal) for testing conducted after 10 minutes of dark adaptation.
Measured: (During first & only study visit) Dark-adapted ERG test following 10 minutes of dark adaptation
Rate of classification (normal vs abnormal) for ERG following 20 minute dark adaptation
The rate of classification (normal vs abnormal) for testing conducted after 20 minutes of dark adaptation.
Measured: (During first & only study visit) Dark-adapted ERG test following 20 minutes of dark adaptation
Secondary outcomes (6)
Response amplitude after 10 minutes
Measurement of the amplitude of responses following 10 minutes of dark adaptation.
Measured: (During first & only study visit) Dark-adapted ERG test following 10 minutes of dark adaptation
Response amplitude after 20 minutes
Measurement of the amplitude of responses following 20 minutes of dark adaptation.
Measured: (During first & only study visit) Dark-adapted ERG test following 20 minutes of dark adaptation
Response timing
Measurement of the amplitude of responses following 10 minutes of dark adaptation.
Measured: (During first & only study visit) Dark-adapted ERG test following 10 minutes of dark adaptation
Response timing
Measurement of the amplitude of responses following 20 minutes of dark adaptation.
Measured: (During first & only study visit) Dark-adapted ERG test following 20 minutes of dark adaptation
Response variability
Measurement of the variability of responses following 10 minutes of dark
Measured: (During first & only study visit) Dark-adapted ERG test following 10 minutes of dark adaptation
Response variability
Measurement of the variability of responses following 20 minutes of dark
Measured: (During first & only study visit) Dark-adapted ERG test following 20 minutes of dark adaptation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2017
- Study startOct 2017 (estimated)
- Primary completionFeb 2018 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dark-adapted ERGStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 262 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ruth Hamilton, PhD, Study director, NHS Greater Glasgow and ClydeKirsten Graham, MSc, Principal investigator, NHS Greater Glasgow and ClydeRichard Hagan, PhD, Principal investigator, NHS Royal Liverpool University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03275441
- Sponsor's protocol ID
- GN17OP146
- Acronym
- SHERG
- Status last verified
- Sep 2017
- First submitted
- 22 Mar 2017
- Last updated
- 7 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of a Protocol Change (Shorter Dark-adaptation) on the Electroretinogram (ERG) in an Adult Patient Population (SHERG)
- ClinicalTrials.gov ID
- NCT03275441
- Acronym / sponsor ID
- SHERG / GN17OP146
- Conditions
- Dark-adapted ERG
- Keywords
- electroretinogram, ERG, dark-adaptation, ophthalmology, electrophysiology, ISCEV, electroretinography, scotopic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 262 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Study start
- Oct 2017 (estimated)
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 7 Sep 2017 (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.
The study evaluates whether an eye test called an electroretinogram (ERG) can be shortened and still produce the same diagnostic results. The results of this study may allow test times to be reduced which will have benefits such as improved patient compliance during shorter testing and increased clinic efficiency.
Detailed description
A full-field electroretinogram (ERG) is a standardised eye test undertaken in specialist hospital clinics. ERGs are useful for diagnosing and monitoring retinal diseases. The retina is stimulated by showing patients flashes of light and the resulting electrical response from the eye is recorded using delicate electrodes that touch the surface of the eye. For the first section of the test, patient's eyes are allowed to adjust to the dark to ensure the parts of the retina responsible for seeing in dimly-lit conditions are being tested.
The international ERG Standard says patients must sit in the dark for 20 minutes. The investigators have evidence to suggest the test may be equally useful after only 10 minutes in the dark. The investigators plan to compare ERGs recorded from patients who have spent only 10 minutes in the dark with ERGs recorded from the same patients after the full 20 minutes in the dark. If the difference is suitably small, as found in a preliminary study of healthy individuals, it could be justifiable to shorten the routine patient protocol.
Subjects for this study will be recruited from the adult population routinely attending for an outpatient ERG test. During their routine ERG test, 10 minutes into the 20 minute wait in the dark, the investigators propose recording an additional, identical set of ERG tests. This will not add extra time to the clinical test.
Participants will not need any follow-up for the research study. The study requires 262 patients to test the hypothesis, and the investigators estimate this will take about 5-6 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients | – | Diagnostic Test: ElectroretinographyAdult patients attending hospital for clinical visual electrophysiology. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patient population attending hospital for routine clinical electroretinography.
Key inclusion criteria (3 listed)
- Patients referred to the adult visual electrophysiology service regardless of clinical condition, and who require dark-adapted electroretinography as part of their appointment
- Male or female
- All ethnicities
Key exclusion criteria (4 listed)
- Patients less than 18 years old
- Patients who might have difficulties understanding the participant information provided (for example, those patients requiring a translator, or who have learning difficulties)
- Patients with photosensitive epilepsy
- Patients appointed for clinical testing urgently, or via telephone, who will not have had an opportunity to receive and review the participant information sheet ahead of the clinical appointment.
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 |
|---|---|---|
| ElectroretinographyAn additional electroretinogram performed after 10 minutes of dark adaptation. | Diagnostic test | Adult patients |
Primary outcome
Rate of classification for ERG following 10 minute dark adaptation
Time frame: (During first & only study visit) Dark-adapted ERG test following 10 minutes of dark adaptation
The rate of classification (normal vs abnormal) for testing conducted after 10 minutes of dark adaptation.
Rate of classification (normal vs abnormal) for ERG following 20 minute dark adaptation
Time frame: (During first & only study visit) Dark-adapted ERG test following 20 minutes of dark adaptation
The rate of classification (normal vs abnormal) for testing conducted after 20 minutes of dark adaptation.
6 secondary outcomes
Response amplitude after 10 minutes
Time frame: (During first & only study visit) Dark-adapted ERG test following 10 minutes of dark adaptation
Response amplitude after 20 minutes
Time frame: (During first & only study visit) Dark-adapted ERG test following 20 minutes of dark adaptation
Response timing
Time frame: (During first & only study visit) Dark-adapted ERG test following 10 minutes of dark adaptation
Response timing
Time frame: (During first & only study visit) Dark-adapted ERG test following 20 minutes of dark adaptation
Response variability
Time frame: (During first & only study visit) Dark-adapted ERG test following 10 minutes of dark adaptation
Response variability
Time frame: (During first & only study visit) Dark-adapted ERG test following 20 minutes of dark adaptation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2017.
- Individual participant dataSharing planned: No
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.
Ruth Hamilton, PhD study director
NHS Greater Glasgow and Clyde
Kirsten Graham, MSc principal investigator
NHS Greater Glasgow and Clyde
Richard Hagan, PhD principal investigator
NHS Royal Liverpool University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Dark-adapted ERG, run by NHS Greater Glasgow and Clyde.
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 3 inclusion and 4 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 7 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
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 Ruth Hamilton, PhD (01414524217, ruth.hamilton@glasgow.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of classification for ERG following 10 minute dark adaptation (time frame: (During first & only study visit) Dark-adapted ERG test following 10 minutes of dark adaptation). 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 7 Sep 2017.