Increased Intracranial PressureNCT05891678
The Value of Doppler Study of Central Retinal Artery in Diagnosis of Increased ICP
A study testing doppler study of central retinal artery in people with Increased Intracranial Pressure, run by Inas Ahmed Sayed Ammar at 1 site in Egypt.
Trial summary
The purpose of this study is to evaluate the diagnostic value of central retinal artery Doppler study in case of increased intracranial pressure. Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Increased Intracranial Pressure
- What is being tested?
- doppler study of central retinal artery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Oct 2023to 15 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All Patients with cerebral stroke either ischemic or hemorrhagic
- All Patients with traumatic brain injury including those on mechanical ventilation
Who cannot join
- Patients with eye trauma
- Patients with either arteritic or non arteritic central retinal artery occlusion
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Cairo university Kas AL- Ainy Fuculty of medicine
Cairo, Cairo Governorate, 12613
About this study
The purpose of this study is to evaluate the diagnostic value of central retinal artery Doppler study in case of increased intracranial pressure.
Read the detailed description
In neurocritical care, the detection of raised intracranial pressure (ICP) remains crucial as it is associated with poor outcome . Invasive ventricular devices are the gold standard for continuous and reliable measurement of ICP however their placement could be challenging due to blood coagulation disorder or lack of surgical availability. Moreover, malfunction or obstruction of ventricular catheters has been reported to occur as often as 6%. Recently Julie.et al. revealed in his met analysis that optic nerve sheath diameter (ONSD) has a good level of diagnostic accuracy for detecting intracranial hypertension with a pooled sensitivity of 0.9. The central retinal artery (CRA) is an end artery branch of the internal carotid artery that joins the optic nerve 1cm behind the globe and enters the retina on the optic nerve head . Central retinal artery is located inside the optic nerve sheath, and The optic nerve is part of the central nervous system and the intraorbital subarachnoid space surrounding the optic nerve is subject to the same pressure changes as the intracranial compartment,so we should expect any increase of ICP will compress the central retinal artery exactly the same as basal cerebral arteries. Central retinal artery circulation is low resistance circulation with good diastolic flow and upper limit of resistivity index is 0.7. So, any compression of CRA will decrease the diastolic flow and increase RI. Kamil.et al. studied the blood flow velocity changes in orbital arteries by using Doppler sonography in eight patients with brain death and increased ICP. Peak systolic and end-diastolic velocities and resistive indices of the ophthalmic and central retinal arteries were evaluated. they observed the absence or reversal of end diastolic blood flow in these arteries. If the intracranial pressure is higher than the end-diastolic pressure of the cerebral arteries diastolic flow reversal occurs. If the intracranial pressure exceeds systolic pressure blood flow is entirely ceased with complete and irreversible loss of brain function CRA is a superficial, easy accessible without bony obstacle like transcranial doppler (TCD) and the learning curve of its Doppler study can be very steep, so it could has a big role in management of cases with increased ICP.
- Conditions
- Increased Intracranial Pressure
- Being tested
- doppler study of central retinal artery
- Medical subject headings
- Intracranial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
doppler study of central retinal arteryRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Radiation: doppler study of central retinal artery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start15 Oct 2023
- Primary completion15 Oct 2025
- Study completion15 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Increased Intracranial PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inas Ahmed Sayed Ammar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Inas Ahmed Sayed Ammar, Cairo University
- Investigators
- Mahmoud Saad Abd Al-Latif Nwar, Lecturer, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05891678
- Sponsor's protocol ID
- CRA doppler in increased ICP
- Status last verified
- Nov 2023
- First submitted
- 3 Mar 2023
- Last updated
- 19 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Doppler Study of Central Retinal Artery in Diagnosis of Increased ICP
- ClinicalTrials.gov ID
- NCT05891678
- Acronym / sponsor ID
- CRA doppler in increased ICP
- Conditions
- Increased Intracranial Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Inas Ahmed Sayed AmmarUniversity, hospital or other
- Study start
- 15 Oct 2023 (actual)
- Primary completion
- 15 Oct 2025 (actual)
- Study completion
- 15 Oct 2025 (actual)
- First posted
- 7 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the diagnostic value of central retinal artery Doppler study in case of increased intracranial pressure.
Detailed description
In neurocritical care, the detection of raised intracranial pressure (ICP) remains crucial as it is associated with poor outcome . Invasive ventricular devices are the gold standard for continuous and reliable measurement of ICP however their placement could be challenging due to blood coagulation disorder or lack of surgical availability. Moreover, malfunction or obstruction of ventricular catheters has been reported to occur as often as 6%. Recently Julie.et al. revealed in his met analysis that optic nerve sheath diameter (ONSD) has a good level of diagnostic accuracy for detecting intracranial hypertension with a pooled sensitivity of 0.9. The central retinal artery (CRA) is an end artery branch of the internal carotid artery that joins the optic nerve 1cm behind the globe and enters the retina on the optic nerve head . Central retinal artery is located inside the optic nerve sheath, and The optic nerve is part of the central nervous system and the intraorbital subarachnoid space surrounding the optic nerve is subject to the same pressure changes as the intracranial compartment,so we should expect any increase of ICP will compress the central retinal artery exactly the same as basal cerebral arteries. Central retinal artery circulation is low resistance circulation with good diastolic flow and upper limit of resistivity index is 0.7. So, any compression of CRA will decrease the diastolic flow and increase RI. Kamil.et al. studied the blood flow velocity changes in orbital arteries by using Doppler sonography in eight patients with brain death and increased ICP. Peak systolic and end-diastolic velocities and resistive indices of the ophthalmic and central retinal arteries were evaluated. they observed the absence or reversal of end diastolic blood flow in these arteries. If the intracranial pressure is higher than the end-diastolic pressure of the cerebral arteries diastolic flow reversal occurs. If the intracranial pressure exceeds systolic pressure blood flow is entirely ceased with complete and irreversible loss of brain function CRA is a superficial, easy accessible without bony obstacle like transcranial doppler (TCD) and the learning curve of its Doppler study can be very steep, so it could has a big role in management of cases with increased ICP.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group (N) | No intervention | –Central retinal artery Doppler in patient with normal ICP |
| Intervention group (H) | Active comparator | Radiation: doppler study of central retinal arteryCentral retinal artery Doppler in patient with increased ICP |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- All Patients with cerebral stroke either ischemic or hemorrhagic
- All Patients with traumatic brain injury including those on mechanical ventilation
Key exclusion criteria (2 listed)
- Patients with eye trauma
- Patients with either arteritic or non arteritic central retinal artery occlusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| doppler study of central retinal arterypulsed 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. | Radiation | Intervention group (H) |
Primary outcome
Central retinal artery resistivity index
Time frame: 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
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 .
peak systolic velocity ( cm/s)
Time frame: 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
on a doppler waveform PSV correspond to each tall "peak " in the spectrum window calculated by build in software
end diastolic velocity ( cm/s )
Time frame: 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
on a doppler waveform EDV correspond to the point marked at the end of the cardiac cycle calculated by build in software
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahmoud Saad Abd Al-Latif Nwar, Lecturer study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing doppler study of central retinal artery in people with Increased Intracranial Pressure, run by Inas Ahmed Sayed Ammar at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central retinal artery resistivity index (time frame: 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.