Actively Recruiting
Assessment of Pupillary Response and Visual Field Defects by Objective Multifocal Chromatic Pupillometer in Patients With Pseudotumor Cerebri and Healthy Subjects
Led by Sheba Medical Center · Updated on 2025-10-06
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Patients with Pseudotumor Cerebri (PTC) may experience increased pressure inside the skull, leading to pressure on the optic nerve and potential vision loss. This condition is usually evaluated by measuring peripheral visual field sensitivity. Researchers are studying the use of chromatic multifocal pupillometry, a quick and noninvasive method, to assess visual function in PTC patients. The study uses an objective chromatic multifocal pupillometer to measure pupils' responses to different colored lights at various wavelengths, intensities, and visual field locations. Both PTC patients and healthy subjects will participate. The primary focus is on measuring pupil contraction and dilation percentages, their speed, and response latency using this device during a single visit. Participants will undergo eye exams including visual field testing and optic nerve imaging with OCT. Measurements will be taken at baseline and repeated at 48 hours, 1 week, and 2 months for PTC patients to track changes over time. The study evaluates pupil responses and visual field defects to better understand PTC's effects and monitor disease progression. The entire assessment is completed within short visits, and no masking or randomization is involved.
CONDITIONS
Brief Title
Multifocal Chromatic Pupilloperimetry in Patients With Pseudotumor Cerebri and Healthy Subjects.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 18 to 80 years
- Written informed consent obtained from all participants
- For healthy subjects: normal eye exam, 20/20 best-corrected visual acuity, normal color vision test, normal OCT, and normal Humphrey visual field test with good reliability
- For PTC patients: at least 20/100 best-corrected visual acuity in worse eye, optic disc edema, and diagnosis of Pseudotumor Cerebri based on Modified Dandy Criteria including lumbar puncture with opening pressure ≥ 25 cm H2O and normal brain imaging except for PTC findings
You will not qualify if you...
- For healthy subjects: history of ocular disease or eye surgery in last 3 months
- Use of medications that affect pupillary reflex
- Intolerance to eye examination procedures such as gonioscopy, slit lamp, or tonometry
- Mental impairment or instability preventing consent or compliance
- Visual media opacity such as cloudy corneas
- Any condition preventing accurate pupil measurement
- For PTC patients: any neurologic or eye disease other than PTC
- Use of medications influencing pupillary reflex
- Intolerance to study eye procedures
- Mental impairment or instability
- Visual media opacity
- Any condition preventing accurate pupil measurement
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day
Participants undergo objective and subjective eye examinations using a chromatic multifocal pupillometer and other visual field tests to assess pupillary responses and visual field defects.
1 visit (in-person)
Duration - 2 months
Participants return for follow-up visits to monitor changes in pupillary responses at 48 hours, 1 week, and 2 months after the initial diagnostic evaluation.
3 visits (in-person) at 48 hours, 1 week, and 2 months post-baseline
Trial Site Locations
Total: 1 location
1
Sheba Medical Center
Tel Litwinsky, Israel, 52621
Actively Recruiting
Research Team
Y
Ygal Rotenstreich, MD
I
Ifat Sher, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here