Multifocal Chromatic Pupilloperimetry in Patients With Pseudotumor Cerebri and Healthy Subjects. (NCT03304314) | Clinical Trial Compass
RecruitingNot Applicable
Multifocal Chromatic Pupilloperimetry in Patients With Pseudotumor Cerebri and Healthy Subjects.
Israel100 participantsStarted 2017-11-03
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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:
✓. Male or female patients, age between 18 and 80 years, inclusive
Exclusion criteria
✕. 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
✕
What they're measuring
1
Measurement of maximal precentage of pupil contraction and dilation in response to chromatic light stimulus
Timeframe: single visit: 1 day
2
Measurement of maximal velocity of pupil contraction and dilation in response to chromatic light stimulus
Timeframe: single visit: 1 day
3
Measurement of latency of pupil contraction and dilation in response to chromatic light stimulus