Radiomic Analysis in OCT Imaging of Acquired Vitelliform Lesions.

NCT ID: NCT07074041

Last Updated: 2025-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-01

Study Completion Date

2025-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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VITELLIFORM LESIONS

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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).

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federico II University

OTHER

Sponsor Role lead

Responsible Party

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Gilda Cennamo

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Naples, Federico II

Napoli, , Italy

Site Status

Countries

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Italy

Other Identifiers

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05809856 Federico II

Identifier Type: -

Identifier Source: org_study_id

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