This study has the following goals: 1. Generation of normative values for full-field ERGs within single recording sessions according to ISCEV standard.2. To compare function (results of full-field ERG) with anatomy (retinal thickness on OCT) in…
ID
Source
Brief title
Condition
- Retina, choroid and vitreous haemorrhages and vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Determinants: age, sex
Outcomes:
ERG: amplitudes and implicit times
OCT: retinal thickness
Secondary outcome
niet van toepassing
Background summary
The International Society for Clinical Electrophysiology of Vision (ISCEV)
demands that each laboratory which records ERGs establishes normative values
for its own equipment and patient population. Age and sex are factors known to
influence ERG outcomes.
Optical Coherence Tomography (OCT) is an imaging technique in which
high-resolution images of ocular structures are generated and is particularly
useful in the diagnosis and management of retinal disorders. The relation
between function and anatomy of the retina in healthy subjects is currently
unclear.
Study objective
This study has the following goals:
1. Generation of normative values for full-field ERGs within single recording
sessions according to ISCEV standard.
2. To compare function (results of full-field ERG) with anatomy (retinal
thickness on OCT) in normal subjects.
Study design
The design is a cross-sectional observational study in which we will perform
full-field ERGs and OCT scans on healthy persons to establish normative values
for our laboratory. Participants will be invited for a one-time
ophthalmological examination, full-field ERG recording and an OCT scan. The
duration of these examinations is approximately two hours per participant; the
entire data collection will take place during one year.
Study burden and risks
The ophthalmologic tests, ERG exam and OCT are non-invasive standard procedures
at our hospital. The pupil dilation with Phenylephrine HCL 2,5% ocgtt and
Tropicamide 0,5% ocgtt is necessary to record an accurate ERG and OCT scan.
Side effects of these drops include photophobia and reduced accommodative power
during 2 hours. There is a very low risk of acute angle-closure glaucoma;
3:10.000 (Wolfs RCW et al; IOVS 1997). If this occurs, we will examine and
treat the patient according to standard care at Dept. Opthalmology at Erasmus
MC.
Dr.Molewaterplein 40
3015 GD Rotterdam
NL
Dr.Molewaterplein 40
3015 GD Rotterdam
NL
Listed location countries
Age
Inclusion criteria
subjects with a visual acuity >= 0.7,
refractive error between +3D and -3D
no history of retinal, neurological or systemic disorders,
no known family history of heritable retinal disease
Exclusion criteria
subjects with a visual acuity <0.7
refractive error not between +3D and -3D
history of retinal, neurological or systemic disorders
family history of heritable retinal disease
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL31882.078.10 |