Intracranial Pressure IncreaseICPNCT03286426
Ocular Screening in Children and Young Adults at Risk for Increased Intracranial Pressure
A study testing Pictor in people with Intracranial Pressure Increase, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the vision and posterior segment of eyes in children and young adults less than 22 years of age with risk, suspicion, or past medical history significant for elevated intracranial pressure (ICP). Patients will have visual acuity and color vision tested. Read more about this study
- Who is it for?
- Ages Up to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Intracranial Pressure Increase
- What is being tested?
- Pictor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2017to 8 Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Capable and willing to provide consent
- Less than 22 years of age
- History of or suspicion for elevated ICP or starting/currently taking high-risk medications associated with increased risk for elevated ICP
Who cannot join
- Unable or unwilling to give consent
- Over 21 years of age
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the vision and posterior segment of eyes in children and young adults less than 22 years of age with risk, suspicion, or past medical history significant for elevated intracranial pressure (ICP). Patients will have visual acuity and color vision tested. Assessment of the posterior segment will involve using a non-invasive (non-contact) imaging technique (i.e. a portable fundus camera in clinic and hospital settings).
Read the detailed description
The need for non-invasive evaluation of ICP is an active area of study. The current gold standard is intraventricular or intraparenchymal catheters but these are invasive, expensive, and require sedation; and thus the need for an effective non-invasive screening tool. The utility of funduscopy in identifying processes affecting ICP has long been recognized, i.e. papilledema, ocular venous engorgement, blurring of the optic disk. Studies have demonstrated that funduscopy may have a role in the qualitative assessment of increased ICP as a highly sensitive test. However, conventional bedside funduscopy does not allow for image capture and may necessitate pupillary dilation. Portable fundus cameras address these issues, allowing image capture and storage and the potential for non-mydriatic imaging, i.e. imaging without dilation of eyes. And as demonstrated in a recent study, portable fundus cameras are efficient (median exam time was 3 minutes and 24 seconds in a pediatric Emergency Department).
Additionally, ICP screening in asymptomatic patients remains limited. Patients being treated with medications for acne, specifically tetracyclines (e.g. minocycline and doxycycline), retinol, and isotretinol, are at particular risk for increased ICP but often are not identified until they are symptomatic (i.e. headaches, visual loss, papilledema). Symptom onset has been documented from 2 weeks up to 1 year from drug initiation. The percentage of patients with subclinical asymptomatic disease is unclear. This study would allow us to describe the presence of subclinical disease in our population and the role/utility of routine non-invasive screening methods.
- Conditions
- Intracranial Pressure Increase
- Being tested
- Pictor
- Keywords
- vision screening, portable fundus camera, acne medication
- Medical subject headings
- Intracranial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PictorDiagnostic test
Also called portable fundus camera
The back of each eye will be imaged with Pictor. Visual acuity and color vision will be checked if patient able to cooperate with exam.
| Study group | Role | What they receive |
|---|---|---|
| Vision/Eye Screening | Experimental | Image of back of each eye along with color vision and visual acuity assessment if able. Receives: Diagnostic Test: Pictor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Posterior Segment as Measured by Fundus Camera
Measured: Each visit (up to 1 hour/visit) every 3 months for 1 year from signed consent
Changes in Visual Acuity
Measured: Each visit (up to 1 hour/visit) every 3 months for 1 year from signed consent
Changes in Color Vision as Measured by Standard Clinical Exam (i.e. Ishihara Testing)
Measured: Each visit (up to 1 hour/visit) every 3 months for 1 year from signed consent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2017
- Study start26 Oct 2017
- Primary completion8 Dec 2018
- Study completion8 Dec 2018
Why it stopped: COVID
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Intracranial Pressure IncreaseStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All patients will have images taken of the back of the eye with a portable fundus camera. If able, visual acuity and color vision will be checked.
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah K Jones, Study director, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03286426
- Sponsor's protocol ID
- Pro00083580
- Acronym
- ICP
- Status last verified
- Jan 2022
- First submitted
- 14 Sep 2017
- Last updated
- 15 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Xu W, Gerety P, Aleman T, Swanson J, Taylor J. Noninvasive methods of detecting increased intracranial pressure. Childs Nerv Syst. 2016 Aug;32(8):1371-86. doi: 10.1007/s00381-016-3143-x. Epub 2016 Jun 28.
PubMed 27351182Roberts E, Morgan R, King D, Clerkin L. Funduscopy: a forgotten art? Postgrad Med J. 1999 May;75(883):282-4. doi: 10.1136/pgmj.75.883.282.
PubMed 10533632Sit M, Levin AV. Direct ophthalmoscopy in pediatric emergency care. Pediatr Emerg Care. 2001 Jun;17(3):199-204; quiz 205-7. doi: 10.1097/00006565-200106000-00013.
PubMed 11437148Petrushkin H, Barsam A, Mavrakakis M, Parfitt A, Jaye P. Optic disc assessment in the emergency department: a comparative study between the PanOptic and direct ophthalmoscopes. Emerg Med J. 2012 Dec;29(12):1007-8. doi: 10.1136/emermed-2011-200038. Epub 2011 Oct 13.
PubMed 21998469Golshani K, Ebrahim Zadeh M, Farajzadegan Z, Khorvash F. Diagnostic Accuracy of Optic Nerve Ultrasonography and Ophthalmoscopy in Prediction of Elevated Intracranial Pressure. Emerg (Tehran). 2015 Spring;3(2):54-8.
PubMed 26495382Day LM, Wang SX, Huang CJ. Nonmydriatic Fundoscopic Imaging Using the Pan Optic iExaminer System in the Pediatric Emergency Department. Acad Emerg Med. 2017 May;24(5):587-594. doi: 10.1111/acem.13128. Epub 2017 Mar 24.
PubMed 27801997Friedman DI. Medication-induced intracranial hypertension in dermatology. Am J Clin Dermatol. 2005;6(1):29-37. doi: 10.2165/00128071-200506010-00004.
PubMed 15675888Chiu AM, Chuenkongkaew WL, Cornblath WT, Trobe JD, Digre KB, Dotan SA, Musson KH, Eggenberger ER. Minocycline treatment and pseudotumor cerebri syndrome. Am J Ophthalmol. 1998 Jul;126(1):116-21. doi: 10.1016/s0002-9394(98)00063-4.
PubMed 9683157
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ocular Screening in Children and Young Adults at Risk for Increased Intracranial Pressure
- ClinicalTrials.gov ID
- NCT03286426
- Acronym / sponsor ID
- ICP / Pro00083580
- Conditions
- Intracranial Pressure Increase
- Keywords
- vision screening, portable fundus camera, acne medication
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 26 Oct 2017 (actual)
- Primary completion
- 8 Dec 2018 (actual)
- Study completion
- 8 Dec 2018 (actual)
- First posted
- 18 Sep 2017 (actual)
- Results
- Posted 15 Feb 2022
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 vision and posterior segment of eyes in children and young adults less than 22 years of age with risk, suspicion, or past medical history significant for elevated intracranial pressure (ICP). Patients will have visual acuity and color vision tested. Assessment of the posterior segment will involve using a non-invasive (non-contact) imaging technique (i.e. a portable fundus camera in clinic and hospital settings).
Detailed description
The need for non-invasive evaluation of ICP is an active area of study. The current gold standard is intraventricular or intraparenchymal catheters but these are invasive, expensive, and require sedation; and thus the need for an effective non-invasive screening tool. The utility of funduscopy in identifying processes affecting ICP has long been recognized, i.e. papilledema, ocular venous engorgement, blurring of the optic disk. Studies have demonstrated that funduscopy may have a role in the qualitative assessment of increased ICP as a highly sensitive test. However, conventional bedside funduscopy does not allow for image capture and may necessitate pupillary dilation. Portable fundus cameras address these issues, allowing image capture and storage and the potential for non-mydriatic imaging, i.e. imaging without dilation of eyes. And as demonstrated in a recent study, portable fundus cameras are efficient (median exam time was 3 minutes and 24 seconds in a pediatric Emergency Department).
Additionally, ICP screening in asymptomatic patients remains limited. Patients being treated with medications for acne, specifically tetracyclines (e.g. minocycline and doxycycline), retinol, and isotretinol, are at particular risk for increased ICP but often are not identified until they are symptomatic (i.e. headaches, visual loss, papilledema). Symptom onset has been documented from 2 weeks up to 1 year from drug initiation. The percentage of patients with subclinical asymptomatic disease is unclear. This study would allow us to describe the presence of subclinical disease in our population and the role/utility of routine non-invasive screening methods.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients will have images taken of the back of the eye with a portable fundus camera. If able, visual acuity and color vision will be checked.
| Arm | Type | Receives |
|---|---|---|
| Vision/Eye Screening | Experimental | Diagnostic Test: PictorImage of back of each eye along with color vision and visual acuity assessment if able. |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Capable and willing to provide consent
- Less than 22 years of age
- History of or suspicion for elevated ICP or starting/currently taking high-risk medications associated with increased risk for elevated ICP
Key exclusion criteria (2 listed)
- Unable or unwilling to give consent
- Over 21 years of age
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 |
|---|---|---|
| PictorAlso: portable fundus cameraThe back of each eye will be imaged with Pictor. Visual acuity and color vision will be checked if patient able to cooperate with exam. | Diagnostic test | Vision/Eye Screening |
Primary outcome
Changes in Posterior Segment as Measured by Fundus Camera
Time frame: Each visit (up to 1 hour/visit) every 3 months for 1 year from signed consent
Changes in Visual Acuity
Time frame: Each visit (up to 1 hour/visit) every 3 months for 1 year from signed consent
Changes in Color Vision as Measured by Standard Clinical Exam (i.e. Ishihara Testing)
Time frame: Each visit (up to 1 hour/visit) every 3 months for 1 year from signed consent
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27351182Xu W, Gerety P, Aleman T, Swanson J, Taylor J. Noninvasive methods of detecting increased intracranial pressure. Childs Nerv Syst. 2016 Aug;32(8):1371-86. doi: 10.1007/s00381-016-3143-x. Epub 2016 Jun 28.
- Background: PubMed 10533632Roberts E, Morgan R, King D, Clerkin L. Funduscopy: a forgotten art? Postgrad Med J. 1999 May;75(883):282-4. doi: 10.1136/pgmj.75.883.282.
- Background: PubMed 11437148Sit M, Levin AV. Direct ophthalmoscopy in pediatric emergency care. Pediatr Emerg Care. 2001 Jun;17(3):199-204; quiz 205-7. doi: 10.1097/00006565-200106000-00013.
- Background: PubMed 21998469Petrushkin H, Barsam A, Mavrakakis M, Parfitt A, Jaye P. Optic disc assessment in the emergency department: a comparative study between the PanOptic and direct ophthalmoscopes. Emerg Med J. 2012 Dec;29(12):1007-8. doi: 10.1136/emermed-2011-200038. Epub 2011 Oct 13.
- Background: PubMed 26495382Golshani K, Ebrahim Zadeh M, Farajzadegan Z, Khorvash F. Diagnostic Accuracy of Optic Nerve Ultrasonography and Ophthalmoscopy in Prediction of Elevated Intracranial Pressure. Emerg (Tehran). 2015 Spring;3(2):54-8.
- Background: PubMed 27801997Day LM, Wang SX, Huang CJ. Nonmydriatic Fundoscopic Imaging Using the Pan Optic iExaminer System in the Pediatric Emergency Department. Acad Emerg Med. 2017 May;24(5):587-594. doi: 10.1111/acem.13128. Epub 2017 Mar 24.
- Background: PubMed 15675888Friedman DI. Medication-induced intracranial hypertension in dermatology. Am J Clin Dermatol. 2005;6(1):29-37. doi: 10.2165/00128071-200506010-00004.
- Background: PubMed 9683157Chiu AM, Chuenkongkaew WL, Cornblath WT, Trobe JD, Digre KB, Dotan SA, Musson KH, Eggenberger ER. Minocycline treatment and pseudotumor cerebri syndrome. Am J Ophthalmol. 1998 Jul;126(1):116-21. doi: 10.1016/s0002-9394(98)00063-4.
- Individual participant dataSharing planned: No
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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.
Sarah K Jones study director
Duke 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 Pictor in people with Intracranial Pressure Increase, run by Duke University at 1 site in United States.
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 3 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: stopped early, as of the sponsor's last update on 15 Feb 2022. 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 United States. 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?
Yes. Results are posted in the registry (first posted 15 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Changes in Posterior Segment as Measured by Fundus Camera (time frame: Each visit (up to 1 hour/visit) every 3 months for 1 year from signed consent). 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?
On the ClinicalTrials.gov record for NCT03286426, which also lists 8 linked publications.
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 15 Feb 2022.