Multifocal Chromatic Pupilloperimetry in Patients With Pseudotumor Cerebri and Healthy Subjects.

NCT ID: NCT03304314

Last Updated: 2025-10-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-03
• Study Completion Date: 2027-12-31

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.

Conditions

Pseudotumor Cerebri

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Pseudotumor cerebri (PTC) patients

Group Type: EXPERIMENTAL

objective chromatic multifocal pupillometer

Intervention Type: DIAGNOSTIC_TEST

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.

Control

Group Type: EXPERIMENTAL

objective chromatic multifocal pupillometer

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dr. Ygal Rotenstreich

Head of ElectrophisiologyClinic and Retinal Research Laboratory

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sheba Medical Center

Tel Litwinsky, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Ygal Rotenstreich, MD

Role: CONTACT

ygal.rotenstreich@sheba.health.gov.il

972-35302880

Ifat Sher, PhD

Role: CONTACT

ifat.sherrosenthal@sheba.health.gov.il

Facility Contacts

Ruth Huna-Baron, MD

Role: primary

Ruth.Huna-Baron@sheba.health.gov.il

97235302536

Lori Gueta

Role: backup

Lori.Gueta@sheba.health.gov.il

972527485888

Other Identifiers

SHEBA-17-3754-YR-CTIL

Identifier Type: -

Identifier Source: org_study_id