Assessing eye function in patients with pseudotumor cerebri using a new pupillometry technique

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Sheba Medical Center
  Tel HaShomer, Israel Recruiting

Study contacts

• Study coordinator: Ygal Rotenstreich, MD
• Email: ygal.rotenstreich@sheba.health.gov.il
• Phone: 972-35302880

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.