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RECRUITING

NCT03304314

Multifocal Chromatic Pupilloperimetry in Patients With Pseudotumor Cerebri and Healthy Subjects.

Sponsor: Sheba Medical Center

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2017-11-03

Completion Date

2027-12-31

Last Updated

2025-10-06

Healthy Volunteers

Yes

Conditions

Pseudotumor Cerebri

Interventions

DIAGNOSTIC_TEST

objective chromatic multifocal pupillometer

objective chromatic multifocal pupillometer (OCMP) enables objective and accurate measurement of pupillary responses to chromatic light at different wavelengths and light intensities and at different visual field locations.

Inclusion Criteria: Healthy subjects 1. Male or female patients, age between 18 and 80 years, inclusive 2. Informed written consent will be obtained from all participants. 3. Normal eye examination 4. Best-corrected visual acuity (BCVA) of 20/20 5. Normal color vision test (Ishihara/HRR) 6. Normal Spectral-Domain Optical Coherence Tomography (SD-OCT) 7. 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 1. Male or female patients, age between 18 and 80 years, inclusive 2. Best-corrected visual acuity (BCVA) of at least 20/100 in worse eye 3. Optic disc edema 4. 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 Criteria: Healthy subjects 1. History of past (last 3 months) or present ocular disease or ocular surgery 2. Use of any topical or systemic medications that could adversely influence pupillary reflex 3. Intolerance to gonioscopy, slit lamp examination, Goldmann applanation tonometry or other schedule study procedure. 4. Mental impairment or instability such as that informed consent may not be obtained or compliance with tester instructions is unlikely. 5. Visual media opacity including cloudy corneas. 6. Any condition preventing accurate measurement or examination of the pupil. PTC patients 1. Any other neurologic or ophthalmic disease other than PTC 2. Use of any topical or systemic medications that could adversely influence pupillary reflex 3. Intolerance to gonioscopy, slit lamp examination, Goldmann applanation tonometry or other schedule study procedure. 4. Mental impairment or instability such as that informed consent may not be obtained or compliance with tester instructions is unlikely. 5. Visual media opacity including cloudy corneas. 6. Any condition preventing accurate measurement or examination of the pupil.

Locations (1)

Sheba Medical Center

Tel Litwinsky, Israel