Assessing eye function in patients with pseudotumor cerebri using a new pupillometry technique
Assessment of Pupillary Response and Visual Field Defects by Objective Multifocal Chromatic Pupillometer in Patients With Pseudotumor Cerebri and Healthy Subjects
This study tests a new eye test to see if it can help find vision problems in people with pseudotumor cerebri compared to healthy individuals.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Sheba Medical Center Government |
| Locations | 1 site (Tel Litwinsky) |
| Trial ID | NCT03304314 on ClinicalTrials.gov |
What this trial studies
This study evaluates the use of chromatic multifocal pupillometry as a noninvasive method to assess visual function in patients with pseudotumor cerebri (PTC) and healthy individuals. The approach aims to measure the impact of increased intracranial pressure on the optic nerve and visual field sensitivity. Participants will undergo objective testing with a specialized pupillometer to determine the feasibility and effectiveness of this technique in identifying visual impairments associated with PTC. The study includes both healthy subjects and patients diagnosed with PTC, ensuring a comprehensive comparison of results.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 80 with a diagnosis of pseudotumor cerebri or healthy individuals with normal eye function.
Not a fit: Patients with significant visual impairment or those who do not meet the inclusion criteria for PTC may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new, noninvasive method for early detection of visual function loss in patients with pseudotumor cerebri.
How similar studies have performed: While pupillometry has been explored in other contexts, this specific application in pseudotumor cerebri is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Tel Litwinsky
- Sheba Medical Center — Tel Litwinsky, Israel (Recruiting)
Study contacts
- Study coordinator: Ygal Rotenstreich, MD
- Email: ygal.rotenstreich@sheba.health.gov.il
- Phone: 972-35302880
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.