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

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ClinicalTrials.gov Identifier: NCT03304314
Recruitment Status : Recruiting
First Posted : October 9, 2017
Last Update Posted : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Ygal Rotenstreich, Sheba Medical Center

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, 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.


Condition or disease Intervention/treatment Phase
Pseudotumor Cerebri Diagnostic Test: objective chromatic multifocal pupillometer Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Assessment of Pupillary Response and Visual Field Defects by Objective Multifocal Chromatic Pupillometer in Patients With Pseudotumor Cerebri and Healthy Subjects
Actual Study Start Date : November 3, 2017
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : October 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pseudotumor cerebri (PTC) patients 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.

Experimental: Control 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 :
  1. Measurement of maximal precentage of pupil contraction and dilation in response to chromatic light stimulus [ Time Frame: single visit: 1 day ]
    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

  2. Measurement of maximal velocity of pupil contraction and dilation in response to chromatic light stimulus [ Time Frame: single visit: 1 day ]
    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

  3. Measurement of latency of pupil contraction and dilation in response to chromatic light stimulus [ Time Frame: single visit: 1 day ]
    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


Secondary Outcome Measures :
  1. Subjective visual field [ Time Frame: single visit: 1 day ]
    Humphrey perimetry

  2. Optic nerve structure by OCT [ Time Frame: single visit: 1 day ]
    OCT imaging

  3. 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 ]
    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

  4. 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 ]
    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

  5. 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 ]
    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

  6. 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 ]
    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

  7. 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 ]
    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

  8. 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 ]
    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

  9. 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 ]
    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

  10. 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 ]
    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

  11. 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 ]
    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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03304314


Contacts
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Contact: Ygal Rotenstreich, MD 972-35302880 ygal.rotenstreich@sheba.health.gov.il
Contact: Ifat Sher, PhD ifat.sherrosenthal@sheba.health.gov.il

Locations
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Israel
Sheba Medical Center Recruiting
Tel HaShomer, Israel, 52621
Contact: Ruth Huna-Baron, MD    97235302536    Ruth.Huna-Baron@sheba.health.gov.il   
Contact: Lori Gueta    972527485888    Lori.Gueta@sheba.health.gov.il   
Principal Investigator: Ruth Huna-Baron, MD         
Sponsors and Collaborators
Sheba Medical Center

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Responsible Party: Dr. Ygal Rotenstreich, Head of ElectrophisiologyClinic and Retinal Research Laboratory, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT03304314     History of Changes
Other Study ID Numbers: SHEBA-17-3754-YR-CTIL
First Posted: October 9, 2017    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Ygal Rotenstreich, Sheba Medical Center:
PTC
EYES
Pseudotumor cerebri
increased Intracranial pressure
ICP
Additional relevant MeSH terms:
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Pseudotumor Cerebri
Intracranial Hypertension
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases