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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
objective chromatic multifocal pupillometer
Diagnostic testobjective 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
Trial outcomes
Primary outcomes
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 outcomes
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
Sponsors and contacts
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