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Clinical Trials/NCT07074041
NCT07074041CompletedNot Applicable

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

Federico II University1 site in 1 country50 target enrollmentStarted: March 1, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
50
Locations
1
Primary Endpoint
Features analysis of aVLs OCT

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Federico II University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Gilda Cennamo

MD

Federico II University

Study Sites (1)

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