NCT05891678

Brief Summary

The purpose of this study is to evaluate the diagnostic value of central retinal artery Doppler study in case of increased intracranial pressure.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 7, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

October 15, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2025

Completed
Last Updated

March 19, 2026

Status Verified

November 1, 2023

Enrollment Period

2 years

First QC Date

March 3, 2023

Last Update Submit

March 18, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Central retinal artery resistivity index

    Central retinal artery resistivity index computed by PSV (cm/s ) and EDV (cm/s) reflects vascular resistance peripheral to the measuring location. The present study evaluate the correlation of Central retinal artery resistive index with increased intracranial pressure .

    From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months

  • peak systolic velocity ( cm/s)

    on a doppler waveform PSV correspond to each tall "peak " in the spectrum window calculated by build in software

    From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months

  • end diastolic velocity ( cm/s )

    on a doppler waveform EDV correspond to the point marked at the end of the cardiac cycle calculated by build in software

    From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months

Study Arms (2)

Control group (N)

NO INTERVENTION

Central retinal artery Doppler in patient with normal ICP

Intervention group (H)

ACTIVE COMPARATOR

Central retinal artery Doppler in patient with increased ICP

Radiation: doppler study of central retinal artery

Interventions

pulsed wave Doppler after decreasing the sample volume to fit inside the center of CRA. We will measure the peak systolic velocity (PSV), end diastolic velocity (EDV), and the resistivity index which equal PSV-EDV/PSV, we will measure 3 times and the expected normal value is less than 0.7.

Intervention group (H)

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All Patients with cerebral stroke either ischemic or hemorrhagic
  • All Patients with traumatic brain injury including those on mechanical ventilation

You may not qualify if:

  • Patients with eye trauma
  • Patients with either arteritic or non arteritic central retinal artery occlusion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo university Kas AL- Ainy Fuculty of medicine

Cairo, Cairo Governorate, 12613, Egypt

Location

MeSH Terms

Conditions

Intracranial Hypertension

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Mahmoud Saad Abd Al-Latif Nwar, Lecturer

    Cairo University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of intensive care unit

Study Record Dates

First Submitted

March 3, 2023

First Posted

June 7, 2023

Study Start

October 15, 2023

Primary Completion

October 15, 2025

Study Completion

October 15, 2025

Last Updated

March 19, 2026

Record last verified: 2023-11

Locations