Actively Recruiting
Multifocal Chromatic Pupilloperimetry in Patients With Pseudotumor Cerebri and Healthy Subjects.
Led by Sheba Medical Center · Updated on 2025-10-06
100
Participants Needed
1
Research Sites
530 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
PTC(Pseudotumor cerebri) patients may develop increased Intracranial pressure (ICP) that can produces increased pressure around the distal optic nerve,which is likely followed by venule compression, ischemia, and loss of visual function.Vision loss in PTC is most commonly characterized by standard automated perimetry to measure peripheral visual field sensitivity. Pupillometry is a promising approach for functional assessment in PTC because it is noninvasive, objective, performed quickly with minimal patient cooperation needed. The feasibility of using chromatic multifocal pupillometry for assesment of PTC will be examined.
CONDITIONS
Official 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 between 18 and 80 years
- Participants who provide informed written consent
- Healthy subjects must have normal eye examinations
- Healthy subjects must have best-corrected visual acuity of 20/20
- Healthy subjects must have normal color vision test results (Ishihara/HRR)
- Healthy subjects must have normal Spectral-Domain Optical Coherence Tomography (SD-OCT)
- Healthy subjects must have normal 24-2 Humphrey visual field (SITA Standard) with short duration and minimal fixation losses, false positive and false negative errors below 33%
- PTC patients must have best-corrected visual acuity of at least 20/100 in the worse eye
- PTC patients must have optic disc edema
- PTC patients must have a PTC diagnosis based on Modified Dandy Criteria, including lumbar puncture with opening pressure ≥ 25 cm H2O, normal cerebrospinal fluid, and typical brain imaging for PTC
You will not qualify if you...
- Healthy subjects with history of ocular disease or eye surgery in the last 3 months
- Use of any topical or systemic medications that may affect pupillary reflex
- Intolerance to gonioscopy, slit lamp examination, Goldmann applanation tonometry, or other study procedures
- Mental impairment or instability preventing informed consent or compliance
- Visual media opacity including cloudy corneas
- Any condition preventing accurate pupil measurement or examination
- PTC patients with any other neurologic or ophthalmic disease besides PTC
- Use of any topical or systemic medications that may affect pupillary reflex
- Intolerance to gonioscopy, slit lamp examination, Goldmann applanation tonometry, or other study procedures
- Mental impairment or instability preventing informed consent or compliance
- Visual media opacity including cloudy corneas
- Any condition preventing accurate pupil measurement or examination
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sheba Medical Center
Tel Litwinsky, Israel, 52621
Actively Recruiting
Research Team
Y
Ygal Rotenstreich, MD
CONTACT
I
Ifat Sher, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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