VITELLIFORM LESIONSNCT07074041
Radiomic Analysis in OCT Imaging of Acquired Vitelliform Lesions.
An observational study of VITELLIFORM LESIONS, run by Federico II University at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- VITELLIFORM LESIONS
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2022to 31 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study group included all patients, over 18 years old, with a diagnosis of aVLs, evaluated from march 2022 to january 2025.
Who may be able to join
- diagnosis of acquired vitelliform lesions
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Radiomic Analysis in Spectral Domain Optical Coherence Tomography 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.
Read more
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
- Medical subject headings
- Ornithine Carbamoyltransferase Deficiency Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start1 Mar 2022
- Primary completion31 Jan 2025
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VITELLIFORM LESIONSStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gilda Cennamo, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07074041
- Sponsor's protocol ID
- 05809856 Federico II
- Status last verified
- Sep 2025
- First submitted
- 12 Jun 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Radiomic Analysis in Spectral Domain Optical Coherence Tomography Imaging of Acquired Vitelliform Lesions.
- ClinicalTrials.gov ID
- NCT07074041
- Acronym / sponsor ID
- 05809856 Federico II
- Conditions
- VITELLIFORM LESIONS
- Keywords
- vitelliform lesion, oct, radiomics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 20 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study group included all patients, over 18 years old, with a diagnosis of aVLs, evaluated from march 2022 to january 2025.
Key inclusion criteria (1 listed)
- diagnosis of acquired vitelliform lesions
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of VITELLIFORM LESIONS, run by Federico II University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Features analysis of aVLs OCT (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.