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OCT and OCTA Deep Learning in Waldenström's Macroglobulinemia Patients

Sponsor
Federico II University (Other)
Overall Status
Completed
CT.gov ID
NCT06084650
Collaborator
(none)
20
Enrollment
1
Location
9
Actual Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study evaluates the ability of deep learning to improve the knowledge about structural and vascular retinal changes in Waldenström's Macroglobulinemia patients, using optical coherence tomography angiography.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Waldenstrom macroglobulinemia (mak-roe-glob-u-lih-NEE-me-uh) is a rare type of cancer that begins in the white blood cells.

    The optical coherence tomography angiography represents a novel and noninvasive diagnostic technique that allows a detailed and quantitative analysis of retinal and choriocapillary vascular features. The study evaluates the changes in optical coherence tomography angiography features in Waldenstrom macroglobulinemia, elaborating these data with artificial intelligence.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    20 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    OCT and OCTA Deep Learning in Waldenström's Macroglobulinemia Patients
    Actual Study Start Date :
    Jan 1, 2023
    Actual Primary Completion Date :
    Sep 30, 2023
    Actual Study Completion Date :
    Oct 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    waldenstrom macroglobulinemia patients
    healthy patients matched age and sex without waldenstrom macroglobulinemia and ocular disease

    Outcome Measures

    Primary Outcome Measures

    1. The measurements of retinal and choriocapillary vessel density in Waldenstrom Macroglobulinemia patients. [up to three months]

      The parameters analyzed by optical coherence tomography angiography were: retinal and choriocapillary vessel density matched with clinical parameters resulted from the artificial pancreas device

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • age older than 18 years

    • diagnosis of Waldenstrom Macroglobulinemia

    • absence of previous ocular surgery and congenital eye diseases.

    • absence of errors of refraction

    • absence of lens opacities

    • absence of low-quality OCT and OCTA images

    Exclusion Criteria:

    • • age younger than 18 years

    • previous ocular surgery and congenital eye diseases

    • errors of refraction

    • lens opacities

    • low-quality OCT and OCTA images

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Naples "Federico II" Naples, Italy, 80100 Contact: Gilda Cennamo, MD 00390817143731 xgilda@hotmail.com Napoli Italy

    Sponsors and Collaborators

    • Federico II University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gilda Cennamo, professor, Federico II University
    ClinicalTrials.gov Identifier:
    NCT06084650
    Other Study ID Numbers:
    • 05809851
    First Posted:
    Oct 16, 2023
    Last Update Posted:
    Oct 16, 2023
    Last Verified:
    Oct 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Waldenstrom Macroglobulinemia

    Study Results

    No Results Posted as of Oct 16, 2023