The primary objective of this pilot study is to determine the clinical value of ocular MRI for patients with the following ocular conditions:- Glaucoma treated with a Baerveldt implant- Visual field loss- Diplopia
ID
Source
Brief title
Condition
- Other condition
- Glaucoma and ocular hypertension
Synonym
Health condition
oogaandoeningen, klachten van het zicht
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
For group 1:
A) The dimensions of the Bleb of the Baerveldt implant after implantation.
For group 2:
A) The presence of an abnormal signal intensity on the optic nerve.
For group 3:
A) Location of the eye relative to the extra ocular muscles.
B) Change in therapy after additional MRI-imaging.
Secondary outcome
For group 1:
A) Location of the Bleb with respect to the extra ocular muscles.
B) Dimensions of the Bleb as measured at the 3Tesla MRI exam
For group 2:
A) Thickness of the optic nerve
For group 3:
N/a
Background summary
MRI is a technique that uses a magnetic field and radio waves to image the
inner part of the human body. It is a patent friendly, non-invasive and
harmless technique. Over the past decadence, MRI has shown to be useful in the
diagnosis and treatment of diseases, in biomedical research and in fundamental
research on the human body.
The sensitivity of MRI to eye-motion, however, has prevented its regular use in
ophthalmology. Recently, a variety of new MRI-techniques has been developed,
allowing the use of MRI for the imaging of the eye and its surrounding tissues.
Study objective
The primary objective of this pilot study is to determine the clinical value of
ocular MRI for patients with the following ocular conditions:
- Glaucoma treated with a Baerveldt implant
- Visual field loss
- Diplopia
Study design
This study will be a multicenter, non-blinded observational study of patients
with various ocular conditions. These patients will receive an 7Tesla ocular
MRI-scan. Eight patients of group 1 (see 'Study population') will also receive
an 3Tesla ocular MRI-scan. All MRI-scans will be performed at the Leiden
University Medical Center.
All patients of group 1 (see 'Study population') will furthermore undergo
several ocular motility measurements in the Rotterdam Eye Hospital.
Study burden and risks
The study consist of one, or in some cases two, ocular MRI-scans, with a
maximum duration of one hour each. When the obtaining informed consent and
similar actions are taken into account, the subjects are requested to be
present for 1,5 hours, or 2,5 hours in the case of two MRI-scans.
All patients of group 1 (see 'Study population') will furthermore undergo
several ocular motility measurements in the Rotterdam Eye Hospital. This will
take at most 1 hour.
The only risks in this study are the risks related to the magnetic field that
is present at the MRI-scanner. By screening the subject for contraindications
for MRI-scanning, this risk is effectively eliminated.
Therefore, the burden associated is low and the risks are negligible
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
The inclusion critria are:
1. One of the specified ocular conditions (see K2 - study population)
2. Age > 18 years
3. Gender: both male and female
4. Written informed consent
Exclusion criteria
The exclusion critria are:
1. Contraindications to (Ophthalmic) MRI scanning, including:
a. Claustrophobia
b. Pregnancy
c. Pacemakers and defibrillators
d. Nerve stimulators
e. Intracranial clips
f. Metallic fragments
g. Cochlear implants
h. Ferromagnetic implants
i. Hydrocephalus pump
j. Permanent make-up
k. Tattoos above the shoulders
l. Piercings (unless they can be taken out)
m. Subjects who cannot keep their head still (e.g. Tremor, Parkinson*s disease)
n. Severe physical restriction (e.g. completely wheelchair dependent);In the case of uncertainty about the MRI-contraindications, the MR-safety commission of the radiology department will decide whether this subject can be included in the study or not.
Design
Recruitment
metc-ldd@lumc.nl
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 | NL65633.058.18 |