Assessment of late effects of radiotherapy in patients with ONSM.
ID
Source
Brief title
Condition
- Ocular neoplasms
- Ocular neoplasms
- Nervous system neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Side effect of radiotherapy:
1. visual deterioration
2. painful eye, dry eye, retinal damage, pituitary function loss
Secondary outcome
3. Preservation or improvement of visual acuity,
4. Health related quality of life
Background summary
Optic nerve sheath meningioma (ONSM) is a rare, slow-growing tumor of the
anterior visual pathway and accounts for 1-2% of all meningiomas (The
Netherlands ~500 new cases per year of whom 5-10 with ONSM). Although the
histological nature of this neoplasm is benign, it causes progressive visual
loss and may ultimately lead to blindness if untreated. High precision
radiotherapy is now the treatment of choice, because it is impossible to
resect the tumor without causing irreversible damage to the optic nerve
resulting in blindness. However, little is known about the late effects of the
radiotherapy either physical (dry eye, painful eye, retina damage with visual
loss, loss of pituitary function) as well as the effect on QoL.
Study objective
Assessment of late effects of radiotherapy in patients with ONSM.
Study design
Observational retrospective study.
Study burden and risks
Burden:
- Standard ophtalmological examnination by an ophtalmologist (non-invasive)
- Fluorescein-angiography of the retinal vessles (intravenous fluorescein 5 ml)
- Blood sample (20 ml)
- Questionnaire (25 multiple choice and open questions)
- Medical history and interview
Total investigation time: 2 hours
Risk:
- Allergic reaction to intravenous fluorescein (rare event <1%)
Meibergdreef 9
1105 AZ Amsterdam
NL
Meibergdreef 9
1105 AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Patients after radiotherapy for ONSM, age >18 yrs
Exclusion criteria
pregnant or breast feeding patients
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 | NL39633.018.12 |