Optical coherence tomography and widefield fundus photography for 3D radiation- dose response relationship in partial eye irradiatio

Recruiting

Conditions: radiation retinopathy
retinal damage after radiation therapy
retinal vasculopathy after radiation
10047060
10027656

Registration Number: NL-OMON52706

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all
the following criteria:
- >18 years of age
- Underwent external beam radiation therapy (EBRT) for sinusoidal tumors,
nasopharyngeal tumor, orbital rhabdomyosarcoma, uveal melanoma or meningioma
for >= 2 years
- Signed informed consent

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded
from participation in this study:
- Any ocular disease / abnormality that prevents good quality imaging of the
retina.
- Any ocular disease / abnormality that presents asymmetrically (affecting one
eye more than the other e.g., anisometropia) that could influence the outcome
measurements and is not related to radiation.
- Other medical conditions which enables patients to participate the study e.g.
psychologically not able to participate or undergoing palliative treatment.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameters/endpoints:<br /><br>- Determine retinopathy and optic neuropathy and translate this to ocular<br /><br>damage map<br /><br>- Develop irradiation dosimetry map of the eye / optic tract<br /><br>- Combine both maps to determine prediction model and NTCP</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- possible other side effects of the eye and/or optic tract caused by<br /><br>irradiation of malignancies arising in the brain, head and neck such as; dry<br /><br>eye, cataract , and scleral necrosis.<br /><br>- the impact on QoL of ocular complications caused by irradiation of the eye<br /><br>and/or optic tract<br /><br>- the influence of concurrent parameters such as hypertension, diabetes<br /><br>mellitus, smoking (previous and history), alcohol intake, dyslipidemia, family<br /><br>history of cardiovascular disease, personal history of cardiovascular disease,<br /><br>cardiovascular risk estimation for the following 10-years (based on the<br /><br>Framingham Coronary Heart Disease Risk Score) on the development of radiation<br /><br>induced retinopathy and optic neuropathy</p><br>