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CompletedNCT06084650OCTAUpdated May 22, 2024

Optical Coherence Tomography (OCT) and OCT Angiography(OCTA) Deep Learning in Waldenström's Macroglobulinemia Patients

An observational study in Waldenstrom Macroglobulinemia, sponsored by Federico II University. Completed at 1 site in Italy. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-22.

Sponsored by Federico II University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
18 Years to 80 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Waldenstrom Macroglobulinemia
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In context

Waldenstrom Macroglobulinemia

365 studies on the registry are indexed under Waldenstrom Macroglobulinemia; 62 are open to participants now.

This study's enrollment of 20 is below the median of 206 across 30 observational studies indexed under Waldenstrom Macroglobulinemia.

Browse Waldenstrom Macroglobulinemia studies →

Lead sponsor

Federico II University is the lead sponsor of 356 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

The participans were older than 18 years with diagnosis of Waldenstrom Macroglobulinemia. They did not present other ophthalmological disease

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (actual)
Target follow-up
1 Year
Patient registry
Yes

Groups and cohorts

  • waldenstrom macroglobulinemia patients
  • healthy patients matched age and sex without waldenstrom macroglobulinemia and ocular disease
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What researchers measure

Primary outcomes

  1. 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

    Time frame: up to three months

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Study locations

1 site
  • University of Naples "Federico II" Naples, Italy, 80100 Contact: Gilda Cennamo, MD 00390817143731 xgilda@hotmail.com
    Napoli, Italy
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06084650
Lead sponsor
Federico II University
Responsible party
Gilda Cennamo (professor, Federico II University) — Principal investigator
First posted
Oct 16, 2023
Start date
Jan 1, 2023
Primary completion
Sep 30, 2023
Completion
Oct 1, 2023
Last update
May 22, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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