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NCT06084650 Clinical Trial

OCT and OCTA Deep Learning in Waldenström's Macroglobulinemia Patients

Waldenstrom Macroglobulinemia Clinical Trial

Official title:
OCT and OCTA Deep Learning in Waldenström's Macroglobulinemia Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06084650
Other study ID # 05809851
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2023
Est. completion date October 1, 2023

Study information
Verified date October 2023
Source Federico II University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date October 1, 2023
Est. primary completion date September 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

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

Sponsors (1)
Lead Sponsor Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary The measurements of retinal and choriocapillary vessel density in Waldenstrom Macroglobulinemia patients. The parameters analyzed by optical coherence tomography angiography were: retinal and choriocapillary vessel density matched with clinical parameters resulted from the artificial pancreas device up to three months
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