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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSheba Medical Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Pseudotumor cerebri (PTC) patientsExperimental treatment 1 intervention
Group B: ControlExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
single visit: 1 day
2

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

Time frame
single visit: 1 day
3

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

Time frame
single visit: 1 day

Secondary outcomes

1

Subjective visual field

Humphrey perimetry

Time frame
single visit: 1 day
2

Optic nerve structure by OCT

OCT imaging

Time frame
single visit: 1 day
3

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

Time frame
single visit: 1 day, 48 hours after baseline testing
4

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

Time frame
single visit: 1 day, 48 hours after baseline testing

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.