NCT03304314 Multifocal Chromatic Pupilloperimetry in Patients With Pseudotumor Cerebri and Healthy Subjects.
| NCT ID | NCT03304314 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sheba Medical Center |
| Condition | Pseudotumor Cerebri |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2017-11-03 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2017-11-03 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03304314 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Pseudotumor Cerebri. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03304314 currently recruiting?
Yes, NCT03304314 is actively recruiting participants. Contact the research team at ygal.rotenstreich@sheba.health.gov.il for enrollment information.
Where is the NCT03304314 trial being conducted?
This trial is being conducted at Tel Litwinsky, Israel.
Who is sponsoring the NCT03304314 clinical trial?
NCT03304314 is sponsored by Sheba Medical Center. The trial plans to enroll 100 participants.