[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100309129":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":11,"centralContacts":23,"locations":32,"responsibleParty":56,"collaborators":11,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":11,"eligibilityCriteria":65,"healthyVolunteers":66,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":11,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":34,"whyStopped":11,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Sheba Medical Center","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Pseudotumor cerebri (PTC) patients","EXPERIMENTAL",null,[13],"Diagnostic Test: objective chromatic multifocal pupillometer",{"label":15,"type":10,"description":11,"interventionNames":16},"Control",[13],[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":11},"DIAGNOSTIC_TEST","objective chromatic multifocal pupillometer","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.",[15,9],[24,29],{"name":25,"role":26,"phone":27,"phoneExt":11,"email":28},"Ygal Rotenstreich, MD","CONTACT","972-35302880","ygal.rotenstreich@sheba.health.gov.il",{"name":30,"role":26,"phone":11,"phoneExt":11,"email":31},"Ifat Sher, PhD","ifat.sherrosenthal@sheba.health.gov.il",[33],{"facility":5,"status":34,"city":35,"state":11,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"RECRUITING","Tel Litwinsky","52621","Israel","IL",{"type":40,"coordinates":41},"Point",[42,43],34.84588,32.05096,{"lat":43,"lon":42},[46,50,54],{"name":47,"role":26,"phone":48,"phoneExt":11,"email":49},"Ruth Huna-Baron, MD","97235302536","Ruth.Huna-Baron@sheba.health.gov.il",{"name":51,"role":26,"phone":52,"phoneExt":11,"email":53},"Lori Gueta","972527485888","Lori.Gueta@sheba.health.gov.il",{"name":47,"role":55,"phone":11,"phoneExt":11,"email":11},"PRINCIPAL_INVESTIGATOR",{"type":55,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Dr. Ygal Rotenstreich","Head of ElectrophisiologyClinic and Retinal Research Laboratory","100309129","multifocal-chromatic-pupilloperimetry-in-patients-with-pseudotumor-cerebri-and-healthy-subjects-100309129",false,"NCT03304314","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","Inclusion Criteria:\n\nHealthy subjects\n\n1. Male or female patients, age between 18 and 80 years, inclusive\n2. Informed written consent will be obtained from all participants.\n3. Normal eye examination\n4. Best-corrected visual acuity (BCVA) of 20\u002F20\n5. Normal color vision test (Ishihara\u002FHRR)\n6. Normal Spectral-Domain Optical Coherence Tomography (SD-OCT)\n7. Normal 24-2 Humphrey visual field (SITA Standard) and:\n\n   * Short duration (≤10 minutes)\n   * Minimal fixation losses, False POS errors and False NEG errors (less than 33% for each one of reliability indices)\n\nPTC patients\n\n1. Male or female patients, age between 18 and 80 years, inclusive\n2. Best-corrected visual acuity (BCVA) of at least 20\u002F100 in worse eye\n3. Optic disc edema\n4. 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\n\nExclusion Criteria:\n\nHealthy subjects\n\n1. History of past (last 3 months) or present ocular disease or ocular surgery\n2. Use of any topical or systemic medications that could adversely influence pupillary reflex\n3. Intolerance to gonioscopy, slit lamp examination, Goldmann applanation tonometry or other schedule study procedure.\n4. Mental impairment or instability such as that informed consent may not be obtained or compliance with tester instructions is unlikely.\n5. Visual media opacity including cloudy corneas.\n6. Any condition preventing accurate measurement or examination of the pupil.\n\nPTC patients\n\n1. Any other neurologic or ophthalmic disease other than PTC\n2. Use of any topical or systemic medications that could adversely influence pupillary reflex\n3. Intolerance to gonioscopy, slit lamp examination, Goldmann applanation tonometry or other schedule study procedure.\n4. Mental impairment or instability such as that informed consent may not be obtained or compliance with tester instructions is unlikely.\n5. Visual media opacity including cloudy corneas.\n6. Any condition preventing accurate measurement or examination of the pupil.",true,"ALL","18 Years","80 Years",{"count":71,"type":72},100,"ESTIMATED","INTERVENTIONAL",[75],"NA","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.\n\nPupillometry is a promising approach for functional assessment in PTC because it is noninvasive, objective, performed quickly with minimal patient cooperation needed.\n\nThe feasibility of using chromatic multifocal pupillometry for assesment of PTC will be examined.",[78],"Pseudotumor Cerebri",[80,81,82,83,84],"PTC","EYES","Pseudotumor cerebri","increased Intracranial pressure","ICP","2025-09-30",{"date":87,"type":88},"2025-10-06","ACTUAL",{"date":90,"type":88},"2017-11-03",{"date":92,"type":72},"2027-12-31",{"name":5,"class":6},1]