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

Sheba Medical Center

Status: Enrolling

Conditions: Pseudotumor Cerebri

Treatments: Diagnostic Test: objective chromatic multifocal pupillometer

Study type: Interventional

Funder types: Other

Identifiers

NCT03304314

SHEBA-17-3754-YR-CTIL

Details and patient eligibility

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Pseudotumor cerebri (PTC) patients

Experimental group

Treatment:

Diagnostic Test: objective chromatic multifocal pupillometer

Control

Experimental group

Treatment:

Diagnostic Test: objective chromatic multifocal pupillometer