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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON52706

Enrollment

100

Registered

2020-09-22

Start date

2020-09-10

Completion date

Unknown

Last updated

2024-08-19

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

Conditions

radiation retinopathy retinal damage after radiation therapy retinal vasculopathy after radiation

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main study parameters/endpoints: - Determine retinopathy and optic neuropathy and translate this to ocular damage map - Develop irradiation dosimetry map of the eye / optic tract - Combine both maps to determine prediction model and NTCP	—

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results