Multifocal Chromatic Pupilloperimetry in Patients With Pseudotumor Cerebri and Healthy Subjects.
- Conditions
- Pseudotumor Cerebri
- Interventions
- Diagnostic Test: objective chromatic multifocal pupillometer
- Registration Number
- NCT03304314
- Lead Sponsor
- Sheba Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
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:
- 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
- Male or female patients, age between 18 and 80 years, inclusive
- Best-corrected visual acuity (BCVA) of at least 20/100 in worse eye
- Optic disc edema
- 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
Healthy subjects
- 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.
- Visual media opacity including cloudy corneas.
- Any condition preventing accurate measurement or examination of the pupil.
PTC patients
- Any other neurologic or ophthalmic disease other than PTC
- 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.
- Visual media opacity including cloudy corneas.
- Any condition preventing accurate measurement or examination of the pupil.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pseudotumor cerebri (PTC) patients objective chromatic multifocal pupillometer - Control objective chromatic multifocal pupillometer -
- Primary Outcome Measures
Name Time Method 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 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 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 Outcome Measures
Name Time Method 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
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 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 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 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 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 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 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
Subjective visual field single visit: 1 day Humphrey perimetry
Optic nerve structure by OCT single visit: 1 day OCT imaging
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
Trial Locations
- Locations (1)
Sheba Medical Center
🇮🇱Tel HaShomer, Israel