Evaluation of Objective Perimetry Using Chromatic Multifocal Pupillometer

Overview

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.

Full Title of Study: “Objective Perimetry in Normal Subjects,Glaucoma Patients and Retinal Dystrophy Patients”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 31, 2025

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

Arms, Groups and Cohorts

  • Healthy subjects
    • Healthy subjects will be used as control group
  • Patients
    • Patients with Glaucoma , Patients with retinal dystrophy

Clinical Trial Outcome Measures

Primary Measures

  • PLR response amplitude and latency
    • Time Frame: single visit

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Sheba Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr. Ygal Rotenstreich, Head of Electrophisiology Unit, Maurice and Gabriela Goldschleger Eye Research Institute – Sheba Medical Center
  • Overall Contact(s)
    • Ygal Rotenstreich, MD, 972547898137, Ygal.Rotenstreich@sheba.health.gov.il

References

Skaat A, Sher I, Kolker A, Elyasiv S, Rosenfeld E, Mhajna M, Melamed S, Belkin M, Rotenstreich Y. Pupillometer-based objective chromatic perimetry in normal eyes and patients with retinal photoreceptor dystrophies. Invest Ophthalmol Vis Sci. 2013 Apr 17;54(4):2761-70. doi: 10.1167/iovs.12-11127.

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