Evaluation of Objective Perimetry Using Chromatic Multifocal Pupillometer

Recruiting

• Conditions: Retinal Dystrophies; Retinitis Pigmentosa; Glaucoma

• Registration Number: NCT02014389
• Lead Sponsor: Sheba Medical Center

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.

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-12-01
• Study First Submitted: 2013-12-12
• Study First Submitted QC: 2013-12-17
• Study First Posted: 2013-12-18
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-24
• Last Update Posted: 2024-04-25
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Age 18-80 years old.
• Signing informed consent.
• Pupillary reflex to light.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PLR response amplitude and latency	single visit

Trial Locations

Locations (1)

Sheba Medical Center; 🇮🇱 Tel HaShomer, Israel