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New treatment option for Pseudotumor Cerebri
Official title Multifocal Chromatic Pupilloperimetry in Patients With Pseudotumor Cerebri and Healthy Subjects.
ClinicalTrials.gov ID: NCT03304314
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80. Healthy volunteers may be eligible.
You may be able to join if
- Healthy people
- 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
You likely can't join if
- Healthy people
- 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.
See the full eligibility criteria
- Healthy people
- 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...
- Healthy people
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Tel Litwinsky, Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tel Litwinsky, Israel. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.