Ocular Screening in Children and Young Adults at Risk for Increased Intracranial Pressure (ICP)
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|ClinicalTrials.gov Identifier: NCT03286426|
Recruitment Status : Recruiting
First Posted : September 18, 2017
Last Update Posted : September 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Intracranial Pressure Increase||Diagnostic Test: Vision/Eye screening||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Intervention 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)|
|Official Title:||Ocular Screening in Children and Young Adults at Risk for Increased Intracranial Pressure|
|Actual Study Start Date :||October 26, 2017|
|Estimated Primary Completion Date :||September 30, 2019|
|Estimated Study Completion Date :||September 30, 2019|
Experimental: Vision/Eye Screening
Image of back of each eye along with color vision and visual acuity assessment if able.
Diagnostic Test: 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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03286426
|Contact: Sasapin G Prakalapakorn, MD||(919)email@example.com|
|United States, North Carolina|
|Durham, North Carolina, United States, 27710|
|Contact: Sasapin G Prakalapakorn, MD, MPH 919-684-7679 firstname.lastname@example.org|
|Study Director:||Sarah K Jones||Duke University|