Assessment of Pupillary Response and Visual Field Defects by Objective Multifocal Chromatic Pupillometer in Patients With Pseudotumor Cerebri and Healthy Subjects

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: t
View:

∙ Healthy subjects

• Male or female patients, age between 18 and 80 years, inclusive

• Informed written consent will be obtained from all participants.

• Normal eye examination

• Best-corrected visual acuity (BCVA) of 20/20

• Normal color vision test (Ishihara/HRR)

• Normal Spectral-Domain Optical Coherence Tomography (SD-OCT)

• Normal 24-2 Humphrey visual field (SITA Standard) and:

‣ Short duration (≤10 minutes)

⁃ Minimal fixation losses, False POS errors and False NEG errors (less than 33% for each one of reliability indices)

∙ PTC patients

• Male or female patients, age between 18 and 80 years, inclusive

• Best-corrected visual acuity (BCVA) of at least 20/100 in worse eye

• Optic disc edema

• PTC diagnosis based on Modified Dandy Criteria ( lumbar puncture with opening pressure higher than or equal to 25 cm H2O, normal cerebrospinal fluid constituents, and unremarkable brain imaging results except typical for PTC

Locations
Other Locations
Israel
Sheba Medical Center
RECRUITING
Tel Litwinsky
Contact Information
Primary
Ygal Rotenstreich, MD
ygal.rotenstreich@sheba.health.gov.il
972-35302880
Backup
Ifat Sher, PhD
ifat.sherrosenthal@sheba.health.gov.il
Time Frame
Start Date: 2017-11-03
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 100
Treatments
Experimental: Pseudotumor cerebri (PTC) patients
Experimental: Control
Sponsors
Leads: Sheba Medical Center

This content was sourced from clinicaltrials.gov