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NCT Number: NCT03304314

Multifocal Chromatic Pupilloperimetry 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.

Recruiting

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Key information

Conditions

Pseudotumor Cerebri Brain Diseases Central Nervous System Diseases Intracranial Hypertension Nervous System Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

objective chromatic multifocal pupillometer

Diagnostic Test

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 outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Ifat Sher, PhD

CONTACT

[email protected]

Ygal Rotenstreich, MD

CONTACT

[email protected]

972-35302880

Sponsors and collaborators

Lead sponsor

Sheba Medical Center

Other Gov

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2027
Study completion
2027
First posted
Oct 9, 2017
Registry last updated
Oct 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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