To investigate to which extent macular function is affected in patients with inflammatory CME as measured by mfERG.
ID
Source
Brief title
Condition
- Eye disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To investigate to which extent macular function is affected in patients with
inflammatory CME as measured by mfERG. Multifocal ERGs will be analyzed on
amplitude, implicit time, and waveform.
Secondary outcome
1. To which extent mfERG abnormalities are reversible after treatment.
2. To which extent clinical parameters, including demographics, treatment and
ophthalmologic examination results (e.g. OCT value, visual acuity, severity of
inflammation scored according to SUN) influence and/or correlate to mfERG
abnormalities.
3. To which extend the 30HZ flicker response can be correlated to the mfERG
and clinical parameters.
Background summary
Uveitis is a major cause of severe visual impairment. It is often chronic and
is treatable with steroids, biologicals and disease-modifying antirheumatic
drugs (DMARDs). However, a series of severe complications can occur. Cystoid
macula edema (CME) is a frequent complication of uveitis and the main cause of
blindness and vision loss. CME is treatable, after which usually vision
improves. However, in some patients vision does not improve after CME
treatment. Complications of treatment of CME include cataracts and an increase
of intraocular pressure. Multifocal electroretinogram(mfERG) is a diagnostic
method for analysis of different regions of the retina, including the macula.
Multifocal ERG can therefore be used to determine macular function in relation
to (chronic) CME. mfERG can therefore give insights in CME.
Study objective
To investigate to which extent macular function is affected in patients with
inflammatory CME as measured by mfERG.
Study design
Pilot study
Study burden and risks
The performance of a mfERG takes approxamately 30-45 minutes, a 30Hz flicker
respons approx. 1 minute.. Patients will have 2 mfERGs and 30Hz flicker
responses. These are non-painfull, non-invasive tests. The risks associated
with a mfERG and 30Hz flicker response are negligible. Disposable DTLs are
used. Eye droplets that are administerd have been administered multiple times
to these patients at routine ophthalmologic visits.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
- Age *18 years
- Inflammatory CME requiring (different) treatment
- Mentally competent
Exclusion criteria
- Age <18 years
- Patients diagnosed with diabetes, a retinal occlusion or other causes of CME.
- Patients with a history of treatment with medication that alter macular function i.e. hydroxychloroquine, tamoxifen.
- Patients with severe puckering
- Patients diagnosed with conditions other than uveitis, that can influence macular function i.e. age related macular degeneration, Stargardt etc.
- Patients with a severe vitreous haze or severe cataracts
Design
Recruitment
Medical products/devices used
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 | NL58823.041.17 |