Status:
RECRUITING
Multifocal Chromatic Pupilloperimetry in Patients With Pseudotumor Cerebri and Healthy Subjects.
Lead Sponsor:
Sheba Medical Center
Conditions:
Pseudotumor Cerebri
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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, i...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Healthy subjects
- History of past (last 3 months) or present ocular disease or ocular surgery
- Use of any topical or systemic medications that could adversely influence pupillary reflex
- Intolerance to gonioscopy, slit lamp examination, Goldmann applanation tonometry or other schedule study procedure.
- Mental impairment or instability such as that informed consent may not be obtained or compliance with tester instructions is unlikely.
- Visual media opacity including cloudy corneas.
- Any condition preventing accurate measurement or examination of the pupil.
- PTC patients
- Any other neurologic or ophthalmic disease other than PTC
- Use of any topical or systemic medications that could adversely influence pupillary reflex
- Intolerance to gonioscopy, slit lamp examination, Goldmann applanation tonometry or other schedule study procedure.
- Mental impairment or instability such as that informed consent may not be obtained or compliance with tester instructions is unlikely.
- Visual media opacity including cloudy corneas.
- Any condition preventing accurate measurement or examination of the pupil.
Key Trial Info
Start Date :
November 3 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03304314
Start Date
November 3 2017
End Date
December 31 2027
Last Update
October 6 2025
Active Locations (1)
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1
Sheba Medical Center
Tel Litwinsky, Israel, 52621