Clinical trial NCT03304314: Multifocal Chromatic Pupilloperimetry in Patients With Pseudotumor Cerebri and Healthy Subjects.
Official title: Assessment of Pupillary Response and Visual Field Defects by Objective Multifocal Chromatic Pupillometer in Patients With Pseudotumor Cerebri and Healthy Subjects
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pseudotumor Cerebri
Keywords: PTC
EYES
Pseudotumor cerebri
increased Intracranial pressure
ICP
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2017-10-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Measurement of maximal precentage of pupil contraction and dilation in response to chromatic light stimulus
timeFrame: single visit: 1 day
measure: Measurement of maximal velocity of pupil contraction and dilation in response to chromatic light stimulus
timeFrame: single visit: 1 day
measure: Measurement of latency of pupil contraction and dilation in response to chromatic light stimulus
timeFrame: single visit: 1 day
Secondary outcomes:
measure: Subjective visual field
timeFrame: single visit: 1 day
measure: Optic nerve structure by OCT
timeFrame: single visit: 1 day
measure: Change from baseline pupil contraction and dilation precentage in PCT patients at 48 hours
timeFrame: single visit: 1 day, 48 hours after baseline testing
measure: Change from baseline pupil contraction and dilation maximal velocity in PCT patients at 48 hours
timeFrame: single visit: 1 day, 48 hours after baseline testing
measure: Change from baseline pupil contraction and dilation latency in PCT patients at 48 hours
timeFrame: single visit: 1 day, 48 hours after baseline testing
measure: Change from baseline pupil contraction and dilation precentage in PCT patients at 1 week.
timeFrame: single visit: 1 day, 1 week after baseline testing
measure: Change from baseline pupil contraction and dilation maximal velocity in PCT patients at 1 week.
timeFrame: single visit: 1 day, 1 week after baseline testing
measure: Change from baseline pupil contraction and dilation latency in PCT patients at 1 week.
timeFrame: single visit: 1 day, 1 week after baseline testing
measure: Change from baseline pupil contraction and dilation precentage in PCT patients at 2 months.
timeFrame: single visit: 1 day, 2 months after baseline testing
measure: Change from baseline pupil contraction and dilation maximal velocity in PCT patients at 2 months.
timeFrame: single visit: 1 day, 2 months after baseline testing
measure: Change from baseline pupil contraction and dilation latency in PCT patients at 2 months.
timeFrame: single visit: 1 day, 2 months after baseline testing
Other outcomes:
Locations:
city: Tel HaShomer
country: Israel
facility: Sheba Medical Center
Study officials:
References: