Evaluation of Objective Perimetry Using Chromatic Multifocal Pupillometer

NCT ID: NCT02014389

Last Updated: 2024-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-12-01

Study Completion Date

2026-12-31

Brief Summary

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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

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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

Conditions

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Retinal Dystrophies Retinitis Pigmentosa Glaucoma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy subjects

Healthy subjects will be used as control group

No interventions assigned to this group

Patients

Patients with Glaucoma , Patients with retinal dystrophy

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Dr. Ygal Rotenstreich

Head of Electrophisiology Unit, Maurice and Gabriela Goldschleger Eye Research Institute

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sheba Medical Center

Tel Litwinsky, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Ygal Rotenstreich, MD

Role: CONTACT

972547898137

Facility Contacts

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Ygal Rotenstreich, MD

Role: primary

97235302880

References

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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.

Reference Type BACKGROUND
PMID: 23482470 (View on PubMed)

Other Identifiers

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SHEBA -13 -0640-YR-CTIL

Identifier Type: -

Identifier Source: org_study_id

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