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NCT06280040 Clinical Trial

Longitudinal Follow-Up of Patients Treated With Hypofractionated Stereotactic Photon Radiotherapy Due to Uveal Melanoma

Uveal Melanoma Clinical Trial

Official title:
Longitudinal Follow-Up of Retinopathy and Opticopathy After Treatment With Hypofractionated Stereotactic Photon Radiotherapy Due to Uveal Melanoma

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06280040
Other study ID # UM Longitudinal 1942/2022
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 23, 2023
Est. completion date June 30, 2025

Study information
Verified date March 2024
Source Medical University of Vienna
Contact Judith Kreminger, MD
Phone 0043 1 40400 48470
Email judith.kreminger@meduniwien.ac.at
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to evaluate the incidence and severity of retinopathy and opticopathy one year after treatment with hypofractionated stereotactic photon radiotherapy due to uveal melanoma. Patients will be imaged before radiation, as well as 3, 6, 9 and 12 months after radiation using sonography funds photography, optical coherence tomography angiography, oximeter and microperimetry.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date June 30, 2025
Est. primary completion date June 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients with newly diagnosed uveal melanoma, who will be treated with hypofractionated stereotactic photon radiotherapy as part of clinical routine. Exclusion Criteria: - unwillingness to participate in the study - severe media opacity

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Clinical examination and multimodal ocular imaging
Imaging consists of sonography, fundus photography, oximeter, optical coherence tomography angiography, and Microperimetry.

Locations
Country Name City State
Austria Department of Ophthalmology and Optometry, Medical University Vienna Vienna

Sponsors (1)
Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence and Severity of Retinopathy Incidence and severity of retinopathy will be evaluated as non-perfusion areas on optical coherence tomography angiography 1 year
Secondary Incidence and Severity of Opticopathy Incidence and severity of retinopathy will be evaluated on clinical examination and fundus photography 1 year
Secondary Functional Outcome Functional outcome will be evaluated as mean retinal sensitivity. 1 year
Secondary Incidence and Severity of Retinopathy and Opticopathy in oximeter Incidence and severity of retinopathy and opticopathy will be evaluated using oxygen saturation 1 year
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