An observational study in Uveal Melanoma, High-risk Uveal Melanoma and Prominent Uveal Melanoma, sponsored by University Hospital, Essen. Recruiting at 3 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by University Hospital, Essen · Observational
High-precision radiosurgery followed by minimally invasive surgical approach in patients with high-prominence uveal melanomas: modern radiation techniques and outcomes. Evaluation of outcome regarding multiparametric parameters and co-factors
The aim here is to prospectively evaluate modern technical standards. The aim of this study is to assess the influence of the updated basic diagnostics and high-resolution diagnostics for radiation planning and the new technical therapy standards (therapy options in application: volume modulated rapid arc technique (VMAT) / online arc technique (VMAT) / online onboard image-guidance (IGRT), by means of the newly established Clinic for Radiation Therapy 2019-2021) depending on known prognostic parameters for quality assurance of the long-term outcome (overall survival, local tumor control). This will lay the basis for standardizing treatment parameters as far as possible, but also to introduce improvements in the treatment of future patients.
Scientific background (state of research (with literature references) and
Derivation of the research question (rationale)):
The eye can be affected by several neoplastic processes, which can lead either primarily or secondary to systemic metastasis. The most common primary tumors of the eye include conjunctival melanoma and uveal melanoma. Metastases from systemic malignant diseases, particularly of the breast and lungs, can also affect the eye.
A combination of ophthalmologic examination, MRI and additional tests and cytologic/histopathologic evaluation leads to an accurate diagnosis.
Depending on the tumor manifestation, treatment consists of a multimodal concept. In the case of uveal melanomas and the aim of preserving the globe and and visual acuity preservation, radiotherapy is one of the most important treatment modalities that can be applied.
In the last 20 years, radiotherapy has developed rapidly away from two-dimensional modulated, three-dimensional techniques. But here too the high level of technical diversity in radiotherapy and ever newer technical innovations, there is a broad spectrum of radiotherapy. Standard therapy can be performed using modern devices, the high-precision stereotactic linear accelerators (irradiation devices), can be safely further optimized. This is to be tested in the Department of Radiotherapy.
281 studies on the registry are indexed under Uveal Melanoma; 50 are open to participants now.
This study's planned enrollment of 250 is above the median of 100 across 37 observational studies indexed under Uveal Melanoma.
Browse Uveal Melanoma studies →University Hospital, Essen is the lead sponsor of 118 studies on the registry; 35 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
- Resectability, high-prominent and high risk uveal melanoma
Exclusion Criteria:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Local control
Local control
Time frame: At 3 months, every 6 months up to 24 months, and annually thereafter up to 60 -120 months.
Function: Visual acuity:
Visual function assessed separately for each eye. Visual acuity: decimal scale,range 2,0 - 0,01: decimal acuity scale
Time frame: At 3 months, every 6 months up to 24 months, and annually thereafter up to 60 -120 months.
Quality of Life, ophthalmic cancer-specific quality of life
Quality of Life, ophthalmic cancer-specific quality of life 1\) EORTC QLQ-OPT30 (ophthalmic cancer-specific quality of life): Scores range from 0-100; higher scores indicate greater visual impairment, ocular symptoms, and functional difficulties.
Time frame: At 3 months, every 6 months up to 24 months, and annually thereafter up to 60 -120 months.
Progression Free Survival
Progression Free Survival
Time frame: At 3 months, every 6 months up to 24 months, and annually thereafter up to 60 -120 months.
Overall Survival
Overall Survival
Time frame: At 3 months, every 6 months up to 24 months, and annually thereafter up to 60 -120 months.
Function: Visual acuity:
Visual function assessed separately for each eye. Visual acuity: decimal scale,range 2,0 - 0,01: decimal acuity scale; furthermore, 1.Count-fingers, 2.hand-motion and 3.light-perception categories are recorded separately when acuity cannot be quantified: for each item: value yes / no
Time frame: At 3 months, every 6 months up to 24 months, and annually thereafter up to 60 -120 months.
Function: Visual field
Visual field: Automated perimetry, Visual Field Index (VFI, %): 0 % - 100%,
Time frame: At 3 months, every 6 months up to 24 months, and annually thereafter up to 60 -120 months.
Quality of Life general quality of life
EORTC QLQ-C30 (general quality of life): Scores range from 0-100; A) higher scores indicate better functioning/global quality of life B) symptom scores: indicate greater symptom burden on symptom scales.
Time frame: At 3 months, every 6 months up to 24 months, and annually thereafter up to 60 -120 months.
Function: Retinal Nerve Fiber Layer
Optical coherence tomography (OCT): Peripapillary retinal nerve fiber layer (RNFL) thickness, measured in µm and classified in percentiles (regarding normal values)
Time frame: At 3 months, every 6 months up to 24 months, and annually thereafter up to 60 -120 months.
Cornea
corneal outcome: thickness measured in µm
Time frame: At 3 months, every 6 months up to 24 months, and annually thereafter up to 60 -120 months.
Cornea
Corneal outcome modified Stocker's classification: category 0 No damage no injury category 1 corneal guttae without epithelial or stromal edema. category 2 corneal guttae with epithelial or stromal edema. category 3 corneal edema associated with scar formation. category 4 corneal opacification with neovascularization, modified Stocker's classification
Time frame: At 3 months, every 6 months up to 24 months, and annually thereafter up to 60 -120 months.
Corneal overall outcome classification
category 0 No corneal-ulcus category 1 Irregular punctate epithelial defects category 2 Non-healing epithelial defects / persistent epithelial defect (PED) category 3 Ulcer perforation
Time frame: At 3 months, every 6 months up to 24 months, and annually thereafter up to 60 -120 months.
Plan to share: Undecided — dependent on the project
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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