Clinical evaluation of ocular MRI for ophthalmic conditions

Completed

• Conditions: oogaandoeningen, klachten van het zicht; glaucoma; high eye pressure; 10018307

• Registration Number: NL-OMON45951
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2020-08-31
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

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.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>For group 1:<br /><br>A) The dimensions of the Bleb of the Baerveldt implant after implantation.<br /><br><br /><br>For group 2:<br /><br>A) The presence of an abnormal signal intensity on the optic nerve.<br /><br><br /><br>For group 3:<br /><br>A) Location of the eye relative to the extra ocular muscles.<br /><br>B) Change in therapy after additional MRI-imaging. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>For group 1:<br /><br>A) Location of the Bleb with respect to the extra ocular muscles.<br /><br>B) Dimensions of the Bleb as measured at the 3Tesla MRI exam<br /><br><br /><br>For group 2:<br /><br>A) Thickness of the optic nerve<br /><br><br /><br>For group 3:<br /><br>N/a</p><br>