An interventional study of objective chromatic multifocal pupillometer in Pseudotumor Cerebri, sponsored by Sheba Medical Center. Recruiting at 1 site in Israel. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-06.
Sponsored by Sheba Medical Center · Not applicable, Interventional, and Diagnostic
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.
53 studies on the registry are indexed under Pseudotumor Cerebri; 22 are open to participants now.
This study's planned enrollment of 100 is above the median of 60 across 35 interventional studies indexed under Pseudotumor Cerebri.
Browse Pseudotumor Cerebri studies →Sheba Medical Center is the lead sponsor of 678 studies on the registry; 63 are open to participants now.
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Healthy subjects
Normal 24-2 Humphrey visual field (SITA Standard) and:
PTC patients
Exclusion Criteria:
Healthy subjects
PTC patients
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Diagnostic Test: objective chromatic multifocal pupillometer
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.
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
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
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
Subjective visual field
Humphrey perimetry
Time frame: single visit: 1 day
Optic nerve structure by OCT
OCT imaging
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: single visit: 1 day, 2 months after baseline testing
Plan to share: No
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Started Nov 2017 (actual). Primary completion is estimated for Dec 2027, 121 months after the start.
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