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CompletedNCT07074041Updated Sep 4, 2025

Radiomic Analysis in OCT Imaging of Acquired Vitelliform Lesions.

An observational study in VITELLIFORM LESIONS, sponsored by Federico II University. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-04.

Sponsored by Federico II University · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • VITELLIFORM LESIONS

Keywords

  • vitelliform lesion
  • oct
  • radiomics
03

In context

Ornithine Carbamoyltransferase Deficiency Disease

35 studies on the registry are indexed under Ornithine Carbamoyltransferase Deficiency Disease; 11 are open to participants now.

This study's enrollment of 50 is below the median of 66 across 20 observational studies indexed under Ornithine Carbamoyltransferase Deficiency Disease.

Browse Ornithine Carbamoyltransferase Deficiency Disease studies →

Lead sponsor

Federico II University is the lead sponsor of 356 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

  • diagnosis of acquired vitelliform lesions

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
50 participants (actual)
Patient registry
No

Groups and cohorts

  • 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).

06

What researchers measure

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

    Time frame: Baseline

07

Study locations

1 site
  • University of Naples, Federico II
    Naples, Italy
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07074041
Lead sponsor
Federico II University
Responsible party
Gilda Cennamo (MD, Federico II University) — Principal investigator
First posted
Jul 20, 2025
Start date
Mar 1, 2022
Primary completion
Jan 31, 2025
Completion
Jan 31, 2025
Last update
Sep 4, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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