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

March 5, 2024 updated by: Reinhard Told, Medical University of Vienna

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Recruiting
        • Department of Ophthalmology and Optometry, Medical University Vienna
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Adrian Reumueller, MD, Priv.-Doz
        • Sub-Investigator:
          • Roman Dunavoelgyi, MD, Assoc.-Prof.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with newly diagnosed uveal melanoma, who will be treated with hypofractionated stereotactic photon radiotherapy as part of clinical routine, will be included in the study.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Uveal Melanoma
Patients with newly diagnosed uveal melanoma, which will be treated with hypofractionated stereotactic photon radiotherapy as clinical routine.
Diagnostic test: Clinical examination and multimodal ocular imaging
Imaging consists of sonography, fundus photography, oximeter, optical coherence tomography angiography, and Microperimetry.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence and Severity of Retinopathy
Time Frame: 1 year
Incidence and severity of retinopathy will be evaluated as non-perfusion areas on optical coherence tomography angiography
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Reinhard Told, MD, PhD, Department for Ophthalmology and Optometry, Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 23, 2023

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

February 20, 2024

First Submitted That Met QC Criteria

February 20, 2024

First Posted (Actual)

February 28, 2024

Study Record Updates

Last Update Posted (Estimated)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UM Longitudinal 1942/2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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