Radiomic Analysis in OCT Imaging of Acquired Vitelliform Lesions.

NCT07074041 | Completed

• 1 other identifier: 05809856 Federico II
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

VITELLIFORM LESIONS

Keywords

vitelliform lesion; oct; radiomics

Outcome Measures

Primary Outcomes (1)

• Features analysis of aVLs OCT

  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

  Baseline

Study Arms (1)

study group

The study population includes patients diagnosed with acquired vitelliforms lesions (aVLs), defined by hyperautofluorescent material on fundus autofluorescence (FAF) and hyperreflective subretinal material on structural optical coherence tomography (OCT).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study group included all patients, over 18 years old, with a diagnosis of aVLs, evaluated from march 2022 to january 2025.

You may qualify if:

• diagnosis of acquired vitelliform lesions

You may not qualify if:

• 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

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

University of Naples, Federico II

Napoli, Italy

Location

MeSH Terms

Conditions

Ornithine Carbamoyltransferase Deficiency Disease

Condition Hierarchy (Ancestors)

Urea Cycle Disorders, Inborn; Brain Diseases, Metabolic, Inborn; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amino Acid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: July 20, 2025
• Study Start: March 1, 2022
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: September 4, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)