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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pseudotumor Cerebri
• Intervention / Treatment: Diagnostic test: objective chromatic multifocal pupillometer

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ygal Rotenstreich, MD; Phone Number: 972-35302880; Email: ygal.rotenstreich@sheba.health.gov.il
• Study Contact Backup: Name: Ifat Sher, PhD; Email: ifat.sherrosenthal@sheba.health.gov.il

Study Locations

• Israel
  • Tel Litwinsky, Israel, 52621
    • Recruiting
    • Sheba Medical Center
    • Contact: Ruth Huna-Baron, MD; Phone Number: 97235302536; Email: Ruth.Huna-Baron@sheba.health.gov.il
    • Principal Investigator: Ruth Huna-Baron, MD
    • Contact: Lori Gueta; Phone Number: 972527485888; Email: Lori.Gueta@sheba.health.gov.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sheba Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2017
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: September 17, 2017
• First Submitted That Met QC Criteria: October 3, 2017
• First Posted (Actual): October 9, 2017

Study Record Updates

• Last Update Posted (Estimated): October 6, 2025
• Last Update Submitted That Met QC Criteria: September 30, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: ICP; PTC; EYES; Pseudotumor cerebri; increased Intracranial pressure
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hypertension; Pseudotumor Cerebri
• Other Study ID Numbers: SHEBA-17-3754-YR-CTIL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No