SVP Detection Using Machine Learning

NCT ID: NCT05731765

Last Updated: 2024-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

210 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-01

Study Completion Date

2024-11-30

Brief Summary

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This diagnostic study will use 410 retrospectively captured fundal videos to develop ML systems that detect SVPs and quantify ICP. The ground truth will be generated from the annotations of two independent, masked clinicians, with arbitration by an ophthalmology consultant in cases of disagreement.

Detailed Description

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Conditions

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Intracranial Pressure Increase

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients aged ≥18 years with presumed normal intracranial pressure

Machine Learning Model

Intervention Type DIAGNOSTIC_TEST

Automated machine learning system for the detection of spontaneous venous pulsations and quantification of intracranial pressure

Patients aged ≥18 years with suspected raised intracranial pressure

Machine Learning Model

Intervention Type DIAGNOSTIC_TEST

Automated machine learning system for the detection of spontaneous venous pulsations and quantification of intracranial pressure

Interventions

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Machine Learning Model

Automated machine learning system for the detection of spontaneous venous pulsations and quantification of intracranial pressure

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patients aged ≥18 years with presumed normal ICP undergoing routine dilated OCT scans.
* Patients undergoing a LP or continuous ICP monitoring with implanted transcranial pressure transducer devices at in- or out-patient neurology, neurosurgery or neuro-ophthalmology services.

Exclusion Criteria

* Glaucoma diagnosis or glaucoma suspects in either eye.
* Bilateral restricted fundal view, e.g. advanced bilateral cataracts.
* Bilateral retinal vein or artery occlusion.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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King's College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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King's College London

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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1.0

Identifier Type: -

Identifier Source: org_study_id

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