An observational study in Dark-adapted ERG, sponsored by NHS Greater Glasgow and Clyde. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-07.
Sponsored by NHS Greater Glasgow and Clyde · Observational
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.
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.
Adult patient population attending hospital for routine clinical electroretinography.
Exclusion Criteria:
Adult patients attending hospital for clinical visual electrophysiology.
Diagnostic Test: Electroretinography
An additional electroretinogram performed after 10 minutes of dark adaptation.
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.
Time frame: (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.
Time frame: (During first & only study visit) Dark-adapted ERG test following 20 minutes of dark adaptation
Response amplitude after 10 minutes
Measurement of the amplitude of responses following 10 minutes of dark adaptation.
Time frame: (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.
Time frame: (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.
Time frame: (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.
Time frame: (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
Time frame: (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
Time frame: (During first & only study visit) Dark-adapted ERG test following 20 minutes of dark adaptation
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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NHS Greater Glasgow and Clyde