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

Recruiting

• Conditions: Uveal Melanoma
• Interventions: Diagnostic Test: Clinical examination and multimodal ocular imaging

• Registration Number: NCT06280040
• Lead Sponsor: Medical University of Vienna

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-23
• Study First Submitted: 2024-02-20
• Study First Submitted QC: 2024-02-20
• Study First Posted: 2024-02-28
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-06
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Uveal Melanoma	Clinical examination and multimodal ocular imaging	Patients with newly diagnosed uveal melanoma, which will be treated with hypofractionated stereotactic photon radiotherapy as clinical routine.

Primary Outcome Measures

Name	Time	Method
Incidence and Severity of Retinopathy	1 year	Incidence and severity of retinopathy will be evaluated as non-perfusion areas on optical coherence tomography angiography

Secondary Outcome Measures

Name	Time	Method
Functional Outcome	1 year	Functional outcome will be evaluated as mean retinal sensitivity.
Incidence and Severity of Retinopathy and Opticopathy in oximeter	1 year	Incidence and severity of retinopathy and opticopathy will be evaluated using oxygen saturation
Incidence and Severity of Opticopathy	1 year	Incidence and severity of retinopathy will be evaluated on clinical examination and fundus photography

Trial Locations

Locations (1)

Department of Ophthalmology and Optometry, Medical University Vienna; 🇦🇹 Vienna, Austria