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Completed

NCT Number: NCT07074041

Radiomic Analysis in OCT Imaging of Acquired Vitelliform Lesions.

Vitelliform lesions (VLs) are subretinal accumulations of yellowish material on fundoscopy that correspond to hyperautofluorescent material on fundus autofluorescence (FAF) and hyperreflective subretinal material on structural optical coherence tomography (OCT).

VLs are characterised by dynamic changes with progressive resorption of material and are associated with the appearance of visual symptoms, such as reduced visual acuity. The appearance of symptoms and changes in the characteristics of the VLs on retinal imaging are the basis of a sophisticated differential diagnosis, especially to distinguish a neovascular from a non-vascular sub-type.

To date, additional retinal imaging techniques can be helpful in performing differential diagnosis in unclear cases. Radiomics is a quantitative approach to medical imaging that can extract many features to improve medical diagnosis and assess response to treatment.

The aim of this study is to evaluate the performance of radiomics in the diagnosis of dynamic changes in VLs.

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Key information

Conditions

VITELLIFORM LESIONS Amino Acid Metabolism, Inborn Errors Brain Diseases Brain Diseases, Metabolic Brain Diseases, Metabolic, Inborn Central Nervous System Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Metabolic Diseases Metabolism, Inborn Errors Nervous System Diseases Nutritional and Metabolic Diseases Ornithine Carbamoyltransferase Deficiency Disease Urea Cycle Disorders, Inborn

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Naples, Federico II

Naples, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diagnosis of acquired vitelliform lesions

Exclusion criteria

  • age < 18 years
  • axial length higher than 26 mm
  • the presence of clinically significant cataract
  • the presence of significant concomitant ocular or systemic diseases (such as diabetic retinopathy, uveitis, glaucoma)
  • known retinal disorders that could cause vitelliform lesions or retinal fluid (AMD, neovascularization, tractional pathologies, toxic or paraneoplastic syndromes)
  • inherited dystrophies

Treatment and study plan

Primary outcomes

  1. Features analysis of aVLs OCT

    Time frame: Baseline

    extraction and analysis of radiomic features from OCT images to characterize empty optical spaces and distinguish empty space in dynamic changes of aVLs from the presence of fluid in case of aVLs complicated by neovascularisation

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

The Role of Radiomic Analysis in Spectral Domain Optical Coherence Tomography Imaging of Acquired Vitelliform Lesions.

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jul 20, 2025
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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