search
Back to results

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

Primary Purpose

Pseudotumor Cerebri

Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
objective chromatic multifocal pupillometer
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pseudotumor Cerebri focused on measuring PTC, EYES, Pseudotumor cerebri, increased Intracranial pressure, ICP

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Sheba Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Pseudotumor cerebri (PTC) patients

Control

Arm Description

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

Subjective visual field
Humphrey perimetry
Optic nerve structure by OCT
OCT imaging
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
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
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
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
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
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
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
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
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

Full Information

First Posted
September 17, 2017
Last Updated
January 15, 2023
Sponsor
Sheba Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT03304314
Brief Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 3, 2017 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheba Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pseudotumor Cerebri
Keywords
PTC, EYES, Pseudotumor cerebri, increased Intracranial pressure, ICP

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pseudotumor cerebri (PTC) patients
Arm Type
Experimental
Arm Title
Control
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
objective chromatic multifocal pupillometer
Intervention Description
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 Measure Information:
Title
Measurement of maximal precentage of pupil contraction and dilation in response to chromatic light stimulus
Description
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
Time Frame
single visit: 1 day
Title
Measurement of maximal velocity of pupil contraction and dilation in response to chromatic light stimulus
Description
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
Time Frame
single visit: 1 day
Title
Measurement of latency of pupil contraction and dilation in response to chromatic light stimulus
Description
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
Time Frame
single visit: 1 day
Secondary Outcome Measure Information:
Title
Subjective visual field
Description
Humphrey perimetry
Time Frame
single visit: 1 day
Title
Optic nerve structure by OCT
Description
OCT imaging
Time Frame
single visit: 1 day
Title
Change from baseline pupil contraction and dilation precentage in PCT patients at 48 hours
Description
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
Time Frame
single visit: 1 day, 48 hours after baseline testing
Title
Change from baseline pupil contraction and dilation maximal velocity in PCT patients at 48 hours
Description
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
Time Frame
single visit: 1 day, 48 hours after baseline testing
Title
Change from baseline pupil contraction and dilation latency in PCT patients at 48 hours
Description
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
Time Frame
single visit: 1 day, 48 hours after baseline testing
Title
Change from baseline pupil contraction and dilation precentage in PCT patients at 1 week.
Description
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
Time Frame
single visit: 1 day, 1 week after baseline testing
Title
Change from baseline pupil contraction and dilation maximal velocity in PCT patients at 1 week.
Description
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
Time Frame
single visit: 1 day, 1 week after baseline testing
Title
Change from baseline pupil contraction and dilation latency in PCT patients at 1 week.
Description
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
Time Frame
single visit: 1 day, 1 week after baseline testing
Title
Change from baseline pupil contraction and dilation precentage in PCT patients at 2 months.
Description
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
Time Frame
single visit: 1 day, 2 months after baseline testing
Title
Change from baseline pupil contraction and dilation maximal velocity in PCT patients at 2 months.
Description
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
Time Frame
single visit: 1 day, 2 months after baseline testing
Title
Change from baseline pupil contraction and dilation latency in PCT patients at 2 months.
Description
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
Time Frame
single visit: 1 day, 2 months after baseline testing

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ygal Rotenstreich, MD
Phone
972-35302880
Email
ygal.rotenstreich@sheba.health.gov.il
First Name & Middle Initial & Last Name or Official Title & Degree
Ifat Sher, PhD
Email
ifat.sherrosenthal@sheba.health.gov.il
Facility Information:
Facility Name
Sheba Medical Center
City
Tel HaShomer
ZIP/Postal Code
52621
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruth Huna-Baron, MD
Phone
97235302536
Email
Ruth.Huna-Baron@sheba.health.gov.il
First Name & Middle Initial & Last Name & Degree
Lori Gueta
Phone
972527485888
Email
Lori.Gueta@sheba.health.gov.il
First Name & Middle Initial & Last Name & Degree
Ruth Huna-Baron, MD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs