Pseudotumor Cerebri
Conditions
Keywords
PTC, EYES, Pseudotumor cerebri, increased Intracranial pressure, ICP
Brief summary
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.
Interventions
DIAGNOSTIC_TESTobjective 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.
Sponsors
Sheba Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy subjects 1. Male or female patients, age between 18 and 80 years, inclusive 2. Informed written consent will be obtained from all participants. 3. Normal eye examination 4. Best-corrected visual acuity (BCVA) of 20/20 5. Normal color vision test (Ishihara/HRR) 6. Normal Spectral-Domain Optical Coherence Tomography (SD-OCT) 7. 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 1. Male or female patients, age between 18 and 80 years, inclusive 2. Best-corrected visual acuity (BCVA) of at least 20/100 in worse eye 3. Optic disc edema 4. 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 1. History of past (last 3 months) or present ocular disease or ocular surgery 2. Use of any topical or systemic medications that could adversely influence pupillary reflex 3. Intolerance to gonioscopy, slit lamp examination, Goldmann applanation tonometry or other schedule study procedure. 4. Mental impairment or instability such as that informed consent may not be obtained or compliance with tester instructions is unlikely. 5. Visual media opacity including cloudy corneas. 6. Any condition preventing accurate measurement or examination of the pupil. PTC patients 1. Any other neurologic or ophthalmic disease other than PTC 2. Use of any topical or systemic medications that could adversely influence pupillary reflex 3. Intolerance to gonioscopy, slit lamp examination, Goldmann applanation tonometry or other schedule study procedure. 4. Mental impairment or instability such as that informed consent may not be obtained or compliance with tester instructions is unlikely. 5. Visual media opacity including cloudy corneas. 6. Any condition preventing accurate measurement or examination of the pupil.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of maximal precentage of pupil contraction and dilation in response to chromatic light stimulus | 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 |
| Measurement of maximal velocity of pupil contraction and dilation in response to chromatic light stimulus | 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 |
| Measurement of latency of pupil contraction and dilation in response to chromatic light stimulus | 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
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline pupil contraction and dilation maximal velocity in PCT patients at 48 hours | 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 |
| Change from baseline pupil contraction and dilation latency in PCT patients at 48 hours | 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 |
| Change from baseline pupil contraction and dilation precentage in PCT patients at 1 week. | 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 |
| Change from baseline pupil contraction and dilation maximal velocity in PCT patients at 1 week. | 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 |
| Subjective visual field | single visit: 1 day | Humphrey perimetry |
| Change from baseline pupil contraction and dilation precentage in PCT patients at 2 months. | 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 |
| Change from baseline pupil contraction and dilation maximal velocity in PCT patients at 2 months. | 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 |
| Change from baseline pupil contraction and dilation latency in PCT patients at 2 months. | 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 |
| Change from baseline pupil contraction and dilation latency in PCT patients at 1 week. | 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 |
| Optic nerve structure by OCT | single visit: 1 day | OCT imaging |
| Change from baseline pupil contraction and dilation precentage in PCT patients at 48 hours | 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 |
Countries
Israel
Contacts
Primary ContactYgal Rotenstreich, MD
Backup ContactIfat Sher, PhD
Outcome results
None listed