NCT03304314Recruiting
Multifocal Chromatic Pupilloperimetry in Patients With Pseudotumor Cerebri and Healthy Subjects.
Assessment of Pupillary Response and Visual Field Defects by Objective Multifocal Chromatic Pupillometer in Patients With Pseudotumor Cerebri and Healthy Subjects
Source: ClinicalTrials.gov · Last updated 6 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 17 Sept 2017
- Start date
- 3 Nov 2017
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Sheba Medical Center
- NCT number
- NCT03304314
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 3 Nov 2017 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of any topical or systemic medications that could adversely influence pupillary reflex
- Use of any topical or systemic medications that could adversely influence pupillary reflex
Other illness
- History of past (last 3 months) or present ocular disease or ocular surgery
- Mental impairment or instability such as that informed consent may not be obtained or compliance with tester instructions is unlikely.
- Any condition preventing accurate measurement or examination of the pupil.
- PTC patients
- Any other neurologic or ophthalmic disease other than PTC
- Mental impairment or instability such as that informed consent may not be obtained or compliance with tester instructions is unlikely.
- Any condition preventing accurate measurement or examination of the pupil.
Other
- Healthy subjects
- Intolerance to gonioscopy, slit lamp examination, Goldmann applanation tonometry or other schedule study procedure.
- Visual media opacity including cloudy corneas.
- Intolerance to gonioscopy, slit lamp examination, Goldmann applanation tonometry or other schedule study procedure.
- Visual media opacity including cloudy corneas.
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sheba medical center Coordinator of this site? Confirm its status | Tel HaShomer | Israel | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.