Intracranial Pressure Increase
Conditions
Keywords
vision screening, portable fundus camera, acne medication
Brief 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. 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.
Interventions
DIAGNOSTIC_TESTPictor
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.
Sponsors
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
No minimum to 21 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* Unable or unwilling to give consent * Over 21 years of age
Design outcomes
Primary
| Measure | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 3 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 3 |
Baseline characteristics
| Characteristic | Vision/Eye Screening |
|---|---|
| Age, Categorical <=18 years | 3 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 59 months STANDARD_DEVIATION 75 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Region of Enrollment United States | 3 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
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
Population: Data not collected as only one visit occurred and a change could not be measured.
Primary
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
Population: Data not collected as only one visit occurred and a change could not be measured.
Primary
Changes in Visual Acuity
Time frame: Each visit (up to 1 hour/visit) every 3 months for 1 year from signed consent
Population: Data not collected as only one visit occurred and a change could not be measured.