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

Pseudotumor Cerebri Clinical Trial

Official title:

Assessment of Pupillary Response and Visual Field Defects by Objective Multifocal Chromatic Pupillometer in Patients With Pseudotumor Cerebri and Healthy Subjects

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03304314
• Other study ID #: SHEBA-17-3754-YR-CTIL
• Status: Recruiting
• Phase: N/A
• Start date: November 3, 2017
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: Sheba Medical Center
• Contact: Ygal Rotenstreich, MD
• Phone: 972-35302880
• Email: ygal.rotenstreich[@]sheba.health.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pseudotumor Cerebri

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Tel HaShomer

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of maximal precentage of pupil contraction and dilation in response to chromatic light stimulus	Percentage of pupil contraction and dilation in response to blue and red light displayed at 76 test targets in a visual field of 30 degree will be measured in PTC patients and compared to matched controls	single visit: 1 day
Primary	Measurement of maximal velocity of pupil contraction and dilation in response to chromatic light stimulus	Pupil contraction and dilation velocity (in pixel/second) in response to blue and red light displayed at 76 test targets in a visual field of 30 degree will be measured in PTC patients and compared to matched controls	single visit: 1 day
Primary	Measurement of latency of pupil contraction and dilation in response to chromatic light stimulus	Pupil contraction and dilation latency (in seconds) in response to blue and red light displayed at 76 test targets in a visual field of 30 degree will be measured in PTC patients and compared to matched controls	single visit: 1 day
Secondary	Subjective visual field	Humphrey perimetry	single visit: 1 day
Secondary	Optic nerve structure by OCT	OCT imaging	single visit: 1 day
Secondary	Change from baseline pupil contraction and dilation precentage in PCT patients at 48 hours	The change in percentage of pupil contraction and dilation in response to blue and red light displayed at 76 test targets in a visual field of 30 degree will be measured in PTC patients 48 hours after baseline measurement	single visit: 1 day, 48 hours after baseline testing
Secondary	Change from baseline pupil contraction and dilation maximal velocity in PCT patients at 48 hours	The change in maximal velocity of pupil contraction and dilation in response to blue and red light displayed at 76 test targets in a visual field of 30 degree will be measured in PTC patients 48 hours after baseline measurement	single visit: 1 day, 48 hours after baseline testing
Secondary	Change from baseline pupil contraction and dilation latency in PCT patients at 48 hours	The change in latency of pupil contraction and dilation in response to blue and red light displayed at 76 test targets in a visual field of 30 degree will be measured in PTC patients 48 hours after baseline measurement	single visit: 1 day, 48 hours after baseline testing
Secondary	Change from baseline pupil contraction and dilation precentage in PCT patients at 1 week.	The change in percentage of pupil contraction and dilation in response to blue and red light displayed at 76 test targets in a visual field of 30 degree will be measured in PTC patients 1 weeks after baseline measurement	single visit: 1 day, 1 week after baseline testing
Secondary	Change from baseline pupil contraction and dilation maximal velocity in PCT patients at 1 week.	The change in maximal velocity of pupil contraction and dilation in response to blue and red light displayed at 76 test targets in a visual field of 30 degree will be measured in PTC patients 1 week after baseline measurement	single visit: 1 day, 1 week after baseline testing
Secondary	Change from baseline pupil contraction and dilation latency in PCT patients at 1 week.	The change in latency of pupil contraction and dilation in response to blue and red light displayed at 76 test targets in a visual field of 30 degree will be measured in PTC patients 1 week after baseline measurement	single visit: 1 day, 1 week after baseline testing
Secondary	Change from baseline pupil contraction and dilation precentage in PCT patients at 2 months.	The change in percentage of pupil contraction and dilation in response to blue and red light displayed at 76 test targets in a visual field of 30 degree will be measured in PTC patients 2 months after baseline measurement	single visit: 1 day, 2 months after baseline testing
Secondary	Change from baseline pupil contraction and dilation maximal velocity in PCT patients at 2 months.	The change in maximal velocity of pupil contraction and dilation in response to blue and red light displayed at 76 test targets in a visual field of 30 degree will be measured in PTC patients 2 months after baseline measurement	single visit: 1 day, 2 months after baseline testing
Secondary	Change from baseline pupil contraction and dilation latency in PCT patients at 2 months.	The change in latency of pupil contraction and dilation in response to blue and red light displayed at 76 test targets in a visual field of 30 degree will be measured in PTC patients 2 months after baseline measurement	single visit: 1 day, 2 months after baseline testing