New eye test may spot vision loss early in brain pressure disorder
NCT ID NCT03304314
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing a new, noninvasive eye test called chromatic multifocal pupillometry to see if it can detect vision problems in people with pseudotumor cerebri (PTC), a condition where increased pressure in the skull can damage the optic nerve and cause vision loss. Researchers will compare the pupil responses of 100 participants (50 with PTC and 50 healthy volunteers) to colored lights. The goal is to find a faster, more objective way to monitor vision loss in PTC patients.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2017
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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Contacts and locations
Locations
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Sheba Medical Center
RECRUITINGTel Litwinsky, 52621, Israel
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