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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pseudotumor cerebri (PTC) patients | Experimental |
| |
| Control | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective visual field | Humphrey perimetry | single visit: 1 day |
| Optic nerve structure by OCT | OCT imaging | single visit: 1 day |
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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:
PTC patients
Exclusion Criteria:
Healthy subjects
PTC patients
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ygal Rotenstreich, MD | Contact | 972-35302880 | ygal.rotenstreich@sheba.health.gov.il | |
| Ifat Sher, PhD | Contact | ifat.sherrosenthal@sheba.health.gov.il |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheba Medical Center | Recruiting | Tel Litwinsky | 52621 | Israel |
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| ID | Term |
|---|---|
| D011559 | Pseudotumor Cerebri |
| D019586 | Intracranial Hypertension |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 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 |