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
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Melanoma
• Uveal Melanoma
• Uveal Neoplasms

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