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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vision/Eye Screening | Experimental | Image of back of each eye along with color vision and visual acuity assessment if able. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pictor | Diagnostic Test | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Posterior Segment as Measured by Fundus Camera | Each visit (up to 1 hour/visit) every 3 months for 1 year from signed consent | |
| Changes in Visual Acuity | 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) | Each visit (up to 1 hour/visit) every 3 months for 1 year from signed consent |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah K Jones | Duke University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke UMC | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27351182 | Background | 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. | |
| 10533632 | Background | Roberts 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Vision/Eye Screening | Image of back of each eye along with color vision and visual acuity assessment if able. Vision/Eye screening: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Vision/Eye Screening | Image of back of each eye along with color vision and visual acuity assessment if able. Vision/Eye screening: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes in Posterior Segment as Measured by Fundus Camera | Data not collected as only one visit occurred and a change could not be measured. | Posted | Each visit (up to 1 hour/visit) every 3 months for 1 year from signed consent |
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At baseline visit as only one visit occurred for each subject.
All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed as there was only one visit per subject for this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vision/Eye Screening | Image of back of each eye along with color vision and visual acuity assessment if able. Vision/Eye screening: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Grace Prakalapakorn | Duke Eye Center | +1 919 684 7679 | grace.prakalapakorn@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 14, 2019 | Dec 7, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D019586 | Intracranial Hypertension |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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.
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|
| 11437148 | Background | Sit 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. |
| 21998469 | Background | Petrushkin 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. |
| 26495382 | Background | Golshani 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. |
| 27801997 | Background | Day 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. |
| 15675888 | Background | Friedman DI. Medication-induced intracranial hypertension in dermatology. Am J Clin Dermatol. 2005;6(1):29-37. doi: 10.2165/00128071-200506010-00004. |
| 9683157 | Background | Chiu 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. |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | months |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Primary | Changes in Visual Acuity | Data not collected as only one visit occurred and a change could not be measured. | Posted | Each visit (up to 1 hour/visit) every 3 months for 1 year from signed consent |
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| Primary | Changes in Color Vision as Measured by Standard Clinical Exam (i.e. Ishihara Testing) | Data not collected as only one visit occurred and a change could not be measured. | Posted | Each visit (up to 1 hour/visit) every 3 months for 1 year from signed consent |
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