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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 below
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study duration, one year is anticipated.
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study duration, one year is anticipated. for reporting.

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 • NCT00881361
8%
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

Ocular Ultrasound Clinical Trial Eligibility Overview. Trial Name: NCT05548335 — N/A
Optic Nerve Research Study Groups: Ocular Ultrasound
Optic Nerve Clinical Trial 2023: Ocular Ultrasound Highlights & Side Effects. Trial Name: NCT05548335 — N/A
Ocular Ultrasound 2023 Treatment Timeline for Medical Study. Trial Name: NCT05548335 — N/A

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."

Answered by AI
~10 spots leftby Dec 2024