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Evaluation of Objective Perimetry Using Chromatic Multifocal Pupillometer

S

Sheba Medical Center

Status

Enrolling

Conditions

Glaucoma
Retinitis Pigmentosa
Retinal Dystrophies

Study type

Observational

Funder types

Other

Identifiers

NCT02014389
SHEBA -13 -0640-YR-CTIL

Details and patient eligibility

About

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 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

Enrollment

200 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

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.

Trial design

200 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Ygal Rotenstreich, MD

Data sourced from clinicaltrials.gov

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