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

Official title

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

Overview

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.

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.

Primary outcome measures

• Measurement of maximal precentage of pupil contraction and dilation in response to chromatic light stimulus [Time frame: single visit: 1 day]
• Measurement of maximal velocity of pupil contraction and dilation in response to chromatic light stimulus [Time frame: single visit: 1 day]
• Measurement of latency of pupil contraction and dilation in response to chromatic light stimulus [Time frame: single visit: 1 day]

Secondary outcome measures (11)

• Subjective visual field [Time frame: single visit: 1 day]
• Optic nerve structure by OCT [Time frame: single visit: 1 day]
• Change from baseline pupil contraction and dilation precentage in PCT patients at 48 hours [Time frame: single visit: 1 day, 48 hours after baseline testing]
• Change from baseline pupil contraction and dilation maximal velocity in PCT patients at 48 hours [Time frame: single visit: 1 day, 48 hours after baseline testing]
• Change from baseline pupil contraction and dilation latency in PCT patients at 48 hours [Time frame: single visit: 1 day, 48 hours after baseline testing]
• Change from baseline pupil contraction and dilation precentage in PCT patients at 1 week. [Time frame: single visit: 1 day, 1 week after baseline testing]
• Change from baseline pupil contraction and dilation maximal velocity in PCT patients at 1 week. [Time frame: single visit: 1 day, 1 week after baseline testing]
• Change from baseline pupil contraction and dilation latency in PCT patients at 1 week. [Time frame: single visit: 1 day, 1 week after baseline testing]
• Change from baseline pupil contraction and dilation precentage in PCT patients at 2 months. [Time frame: single visit: 1 day, 2 months after baseline testing]
• Change from baseline pupil contraction and dilation maximal velocity in PCT patients at 2 months. [Time frame: single visit: 1 day, 2 months after baseline testing]
• Change from baseline pupil contraction and dilation latency in PCT patients at 2 months. [Time frame: single visit: 1 day, 2 months after baseline testing]

Eligibility criteria

Inclusion criteria

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 criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Diagnostic

Study locations

Israel · 1 center

• Sheba Medical Center — Tel Litwinsky

Identifiers

NCT: NCT03304314 · SHEBA-17-3754-YR-CTIL

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗