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Ocular Ultrasound for Optic Nerve Assessment
N/A
Recruiting
Led By Joshua Jacquet, MD
Research Sponsored by Akron General Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18 years of age and older
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study duration, one year is anticipated.
Awards & highlights
Study Summary
This trial looks at how well ocular ultrasound can measure the width of the optic nerve sheath and the diameter of the eyeball in people who come to the emergency room.
Who is the study for?
This trial is for adults over 18 who visit the Cleveland Clinic Akron General's ED, need a CT scan of their head or eyes as part of normal care, and can give written consent. It's not for pregnant or incarcerated individuals, those with eye diseases, abnormal brain/eye CTs, unstable health conditions, or past issues with high pressure in the brain.Check my eligibility
What is being tested?
The study is testing how well ocular ultrasound works to measure optic nerve sheath diameter in healthy patients. Participants will have this non-invasive test alongside standard imaging procedures during their emergency department visit.See study design
What are the potential side effects?
Ocular ultrasound is generally safe and doesn't usually cause side effects. However, there might be some discomfort from holding still during the procedure or minor irritation from the gel used on the skin.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study duration, one year is anticipated.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study duration, one year is anticipated.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The Primary objective is to determine the accuracy of the microconvex ultrasound transducer as compared to the linear ultrasound transducer for ultrasound measurement of the optic nerve sheath diameter compared to CT measurements.
Secondary outcome measures
To determine the accuracy of the microconvex ultrasound transducer as compared to the linear ultrasound transducer for ultrasound measurement of the ONSD/ETD compared to CT measurements.
To determine the accuracy of the microconvex ultrasound transducer as compared to the linear ultrasound transducer for ultrasound measurement of the eyeball transverse diameter compared to CT measurements.
To determine the level of intra- and inter-rater variability for ultrasound measurement of the optic nerve sheath diameter between the two transducer types.
Side effects data
From 2023 Phase 2 trial • 756 Patients • NCT008813618%
Pain
7%
Peripheral sensory neuropathy
6%
Breast pain
6%
Fatigue
3%
Joint disorder
3%
Pain in extremity
2%
Constipation
2%
Nausea
2%
Chest wall pain
2%
Upper extremity dysfunction
2%
Hematoma
2%
Edema limbs
2%
Seroma
1%
Lymphatic disorder
1%
Dizziness
1%
Anxiety
1%
Hot flashes
1%
Hemoglobin decreased
1%
Urine discoloration
1%
Alopecia
1%
Skin disorder
1%
Peripheral motor neuropathy
1%
Insomnia
1%
Fever
1%
Wound infection
1%
Bruising
1%
Myalgia
100%
80%
60%
40%
20%
0%
Study treatment Arm
cN1 Cohort
cN2 Cohort
Trial Design
1Treatment groups
Experimental Treatment
Group I: Ocular UltrasoundExperimental Treatment1 Intervention
This arm includes all patients enrolled who will have an ocular ultrasound with two different probes for a total of four ultrasounds.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ocular Ultrasound
2008
N/A
~40
Find a Location
Who is running the clinical trial?
Akron General Medical CenterLead Sponsor
6 Previous Clinical Trials
248 Total Patients Enrolled
Cleveland Clinic Akron GeneralLead Sponsor
7 Previous Clinical Trials
452 Total Patients Enrolled
Joshua Jacquet, MDPrincipal InvestigatorCleveland Clinic Akron General
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My recent head or eye scans show no signs of acute illness.I have a recent eye condition.I am unable to give consent by myself.I am 18 years old or older.I have had issues with high brain pressure or optic nerve disease.
Research Study Groups:
This trial has the following groups:- Group 1: Ocular Ultrasound
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there currently any participants being recruited for this research?
"As confirmed on clinicaltrials.gov, this medical study is no longer enrolling patients; it was originally posted on October 1st 2022 and the last update occurred on September 22nd 2022. Even so, there are still other opportunities for patient involvement in active trials at this time."
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