Evaluation of Objective Perimetry Using Chromatic Multifocal Pupillometer

Sheba Medical Center (Other)
Overall Status
Unknown status
CT.gov ID

Study Details

Study Description

Brief Summary

Objective perimetry can better monitor visual field defects in retinal dystrophy and Glaucoma patients than conventional subjective perimetry. The PLR ( Pupil Light Reflex to short and long wavelength stimuli should be significantly lower compared to healthy participants in areas of visual field defects in retinal dystrophy and Glaucoma patients.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Pupil light reflex (PLR) will be measured by a chromatic multifocal pupillometer in response to short and long wavelength light with small spot stimulus in 76 points of the 30 degree visual field.

    A computerized infrared video pupillometer will be used to record changes in pupil diameter in response to short- and long-wavelength stimuli (peak 485 nm and 620 nm, respectively) presented by 76 LEDs, 1.8mm spot size, at light intensities of 10-3000 cd/m2 and duration of 1-3 sec at different points of the 30 degree visual field

    Study Design

    Study Type:
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Time Perspective:
    Official Title:
    Objective Perimetry in Normal Subjects,Glaucoma Patients and Retinal Dystrophy Patients
    Study Start Date :
    Dec 1, 2013
    Anticipated Primary Completion Date :
    Dec 31, 2020
    Anticipated Study Completion Date :
    Dec 31, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    Healthy subjects

    Healthy subjects will be used as control group


    Patients with Glaucoma , Patients with retinal dystrophy

    Outcome Measures

    Primary Outcome Measures

    1. PLR response amplitude and latency [single visit]

    Eligibility Criteria


    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:
    Inclusion Criteria:
    • Age 18-80 years old.

    • Signing informed consent.

    • Pupillary reflex to light.

    Exclusion Criteria:
    1. Cloudy corneas.

    2. Surgical intraocular ophthalmic procedure within the past 30 days.

    3. No reactive pupils.

    4. Synechia of the iris to the lens after surgery or inflammation.

    5. Neovascularization.

    6. Axenfeld-Rieger Syndrome.

    7. Iris atrophy (ICE syndrome).

    8. Iris coloboma.

    9. Sphincter damage due to ischemia.

    10. Sphincter damage due to trauma (tears of sphincter or diffuse damage to muscle).

    11. Sphincter damage due to Herpes Zoster Uveitis.

    12. Sphincter damage due to high intraocular pressure.

    13. Iris tumor or cyst.

    14. Ectropion uvae.

    15. Adie's pupil.

    16. Third nerve aberrant regeneration of the iris sphincter.

    17. RP patients with Optic neuropathy with the potential of producing a positive RAPD (Relative Afferent Pupillary Defect).

    18. Chronic use of myotics or mydriatics.

    19. Systemic medication that have affect on pupillary reflex .

    20. Any condition preventing accurate measurement or examination of the pupil.

    Contacts and Locations


    Site City State Country Postal Code
    1 Sheba Medical Center Tel HaShomer Israel 52621

    Sponsors and Collaborators

    • Sheba Medical Center


    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information


    Responsible Party:
    Dr. Ygal Rotenstreich, Head of Electrophisiology Unit, Maurice and Gabriela Goldschleger Eye Research Institute, Sheba Medical Center
    ClinicalTrials.gov Identifier:
    Other Study ID Numbers:
    • SHEBA -13 -0640-YR-CTIL
    First Posted:
    Dec 18, 2013
    Last Update Posted:
    Mar 20, 2020
    Last Verified:
    Mar 1, 2020
    Keywords provided by Dr. Ygal Rotenstreich, Head of Electrophisiology Unit, Maurice and Gabriela Goldschleger Eye Research Institute, Sheba Medical Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 20, 2020