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

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

Conditions
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Pseudotumor Cerebri

Intervention / Treatment
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* Diagnostic Test: objective chromatic multifocal pupillometer


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pseudotumor cerebri (PTC) patients<br> | Diagnostic Test: objective chromatic multifocal pupillometer<br>* 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.<br>|
| Experimental: Control<br> | Diagnostic Test: objective chromatic multifocal pupillometer<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of maximal precentage of pupil contraction and dilation in response to chromatic light stimulus | Percentage of pupil contraction and dilation in response to blue and red light displayed at 76 test targets in a visual field of 30 degree will be measured in PTC patients and compared to matched controls | single visit: 1 day | 
| Measurement of maximal velocity of pupil contraction and dilation in response to chromatic light stimulus | Pupil contraction and dilation velocity (in pixel/second) in response to blue and red light displayed at 76 test targets in a visual field of 30 degree will be measured in PTC patients and compared to matched controls | single visit: 1 day | 
| Measurement of latency of pupil contraction and dilation in response to chromatic light stimulus | Pupil contraction and dilation latency (in seconds) in response to blue and red light displayed at 76 test targets in a visual field of 30 degree will be measured in PTC patients and compared to matched controls | single visit: 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective visual field | Humphrey perimetry | single visit: 1 day | 
| Optic nerve structure by OCT | OCT imaging | single visit: 1 day | 
| Change from baseline pupil contraction and dilation precentage in PCT patients at 48 hours | The change in percentage of pupil contraction and dilation in response to blue and red light displayed at 76 test targets in a visual field of 30 degree will be measured in PTC patients 48 hours after baseline measurement | single visit: 1 day, 48 hours after baseline testing | 
| Change from baseline pupil contraction and dilation maximal velocity in PCT patients at 48 hours | The change in maximal velocity of pupil contraction and dilation in response to blue and red light displayed at 76 test targets in a visual field of 30 degree will be measured in PTC patients 48 hours after baseline measurement | single visit: 1 day, 48 hours after baseline testing | 
| Change from baseline pupil contraction and dilation latency in PCT patients at 48 hours | The change in latency of pupil contraction and dilation in response to blue and red light displayed at 76 test targets in a visual field of 30 degree will be measured in PTC patients 48 hours after baseline measurement | single visit: 1 day, 48 hours after baseline testing | 
| Change from baseline pupil contraction and dilation precentage in PCT patients at 1 week. | The change in percentage of pupil contraction and dilation in response to blue and red light displayed at 76 test targets in a visual field of 30 degree will be measured in PTC patients 1 weeks after baseline measurement | single visit: 1 day, 1 week after baseline testing | 
| Change from baseline pupil contraction and dilation maximal velocity in PCT patients at 1 week. | The change in maximal velocity of pupil contraction and dilation in response to blue and red light displayed at 76 test targets in a visual field of 30 degree will be measured in PTC patients 1 week after baseline measurement | single visit: 1 day, 1 week after baseline testing | 
| Change from baseline pupil contraction and dilation latency in PCT patients at 1 week. | The change in latency of pupil contraction and dilation in response to blue and red light displayed at 76 test targets in a visual field of 30 degree will be measured in PTC patients 1 week after baseline measurement | single visit: 1 day, 1 week after baseline testing | 
| Change from baseline pupil contraction and dilation precentage in PCT patients at 2 months. | The change in percentage of pupil contraction and dilation in response to blue and red light displayed at 76 test targets in a visual field of 30 degree will be measured in PTC patients 2 months after baseline measurement | single visit: 1 day, 2 months after baseline testing | 
| Change from baseline pupil contraction and dilation maximal velocity in PCT patients at 2 months. | The change in maximal velocity of pupil contraction and dilation in response to blue and red light displayed at 76 test targets in a visual field of 30 degree will be measured in PTC patients 2 months after baseline measurement | single visit: 1 day, 2 months after baseline testing | 
| Change from baseline pupil contraction and dilation latency in PCT patients at 2 months. | The change in latency of pupil contraction and dilation in response to blue and red light displayed at 76 test targets in a visual field of 30 degree will be measured in PTC patients 2 months after baseline measurement | single visit: 1 day, 2 months after baseline testing | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PTC, EYES, Pseudotumor cerebri, increased Intracranial pressure, ICP