Pseudotumor CerebriNCT03304314
Multifocal Chromatic Pupilloperimetry in Patients With Pseudotumor Cerebri and Healthy Subjects.
A study testing objective chromatic multifocal pupillometer in people with Pseudotumor Cerebri, run by Sheba Medical Center at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Pseudotumor Cerebri
- What is being tested?
- objective chromatic multifocal pupillometer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 3 Nov 2017to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ifat Sher, PhD contact
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Tel HaShomer, 52621
Ruth Huna-Baron, MD, 97235302536, Ruth.Huna-Baron@sheba.health.gov.il
Lori Gueta, 972527485888, Lori.Gueta@sheba.health.gov.il
About this study
Official title: Assessment of Pupillary Response and Visual Field Defects by Objective Multifocal Chromatic Pupillometer in Patients With Pseudotumor Cerebri and Healthy Subjects
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.
- Conditions
- Pseudotumor Cerebri
- Being tested
- objective chromatic multifocal pupillometer
- Keywords
- PTC, EYES, Pseudotumor cerebri, increased Intracranial pressure, ICP
- Medical subject headings
- Pseudotumor Cerebri, Intracranial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
objective chromatic multifocal pupillometerDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Pseudotumor cerebri (PTC) patients | Experimental | Not described Receives: Diagnostic Test: objective chromatic multifocal pupillometer |
| Control | Experimental | Not described Receives: Diagnostic Test: objective chromatic multifocal pupillometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: single visit: 1 day
Secondary outcomes (11)
Subjective visual field
Humphrey perimetry
Measured: single visit: 1 day
Optic nerve structure by OCT
OCT imaging
Measured: single visit: 1 day
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: single visit: 1 day, 2 months after baseline testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2017
- Study start3 Nov 2017
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pseudotumor CerebriStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Ygal Rotenstreich, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03304314
- Sponsor's protocol ID
- SHEBA-17-3754-YR-CTIL
- Status last verified
- Sep 2025
- First submitted
- 17 Sep 2017
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Pupillary Response and Visual Field Defects by Objective Multifocal Chromatic Pupillometer in Patients With Pseudotumor Cerebri and Healthy Subjects
- ClinicalTrials.gov ID
- NCT03304314
- Acronym / sponsor ID
- SHEBA-17-3754-YR-CTIL
- Conditions
- Pseudotumor Cerebri
- Keywords
- PTC, EYES, Pseudotumor cerebri, increased Intracranial pressure, ICP
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 3 Nov 2017 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pseudotumor cerebri (PTC) patients | Experimental | Diagnostic Test: objective chromatic multifocal pupillometer |
| Control | Experimental | Diagnostic Test: objective chromatic multifocal pupillometer |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| objective chromatic multifocal pupillometerobjective 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. | Diagnostic test | Control, Pseudotumor cerebri (PTC) patients |
Primary outcome
Measurement of maximal precentage of pupil contraction and dilation in response to chromatic light stimulus
Time frame: 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
Time frame: 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
Time frame: 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
11 secondary outcomes
Subjective visual field
Time frame: single visit: 1 day
Optic nerve structure by OCT
Time frame: single visit: 1 day
Change from baseline pupil contraction and dilation precentage in PCT patients at 48 hours
Time frame: single visit: 1 day, 48 hours after baseline testing
Change from baseline pupil contraction and dilation maximal velocity in PCT patients at 48 hours
Time frame: single visit: 1 day, 48 hours after baseline testing
Change from baseline pupil contraction and dilation latency in PCT patients at 48 hours
Time frame: single visit: 1 day, 48 hours after baseline testing
Change from baseline pupil contraction and dilation precentage in PCT patients at 1 week.
Time frame: single visit: 1 day, 1 week after baseline testing
Change from baseline pupil contraction and dilation maximal velocity in PCT patients at 1 week.
Time frame: single visit: 1 day, 1 week after baseline testing
Change from baseline pupil contraction and dilation latency in PCT patients at 1 week.
Time frame: single visit: 1 day, 1 week after baseline testing
Change from baseline pupil contraction and dilation precentage in PCT patients at 2 months.
Time frame: single visit: 1 day, 2 months after baseline testing
Change from baseline pupil contraction and dilation maximal velocity in PCT patients at 2 months.
Time frame: single visit: 1 day, 2 months after baseline testing
Change from baseline pupil contraction and dilation latency in PCT patients at 2 months.
Time frame: single visit: 1 day, 2 months after baseline testing
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ifat Sher, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing objective chromatic multifocal pupillometer in people with Pseudotumor Cerebri, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ygal Rotenstreich, MD (972-35302880, ygal.rotenstreich@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of maximal precentage of pupil contraction and dilation in response to chromatic light stimulus (time frame: single visit: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025.