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Clinical evaluation of ocular MRI for ophthalmic conditions

Clinical evaluation of ocular MRI for ophthalmic conditions - Evaluation of Ocular MRI

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON45951
Enrollment
87
Registered
2018-11-05
Start date
2018-12-14
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

oogaandoeningen, klachten van het zicht glaucoma high eye pressure

Interventions

None listed

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)