Evaluation of Objective Perimetry Using Pupillometer

NCT ID: NCT01021982

Last Updated: 2014-11-19

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

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-11-30

Study Completion Date

2013-01-31

Brief Summary

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Objective perimetry can better monitor visual field defects in RP and Glaucoma patients than conventional subjective perimetry.The PLR ( Pupil Light Reflex ) of the short and long wave ratio should be significantly higher in areas of visual field defects in RP and Glaucoma patients.

Detailed Description

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Pupil light reflex will be measured by a pupillometer in response to short and long wavelength light small spot stimulus in different area of the visual field. The PRL will be measured in four quadrant, central, 10, 20, and 30 degree from the visual axis.

Stimulus duration will be 1000 ms (1 sec), with intervals of 890 ms between stimuli. The stimuli size V with light intensity of 39.8 cd-s/m2 for both short wavelength stimuli (peak 485 nm) and long wavelength stimuli (peak 620nm).

Conditions

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Retinitis Pigmentosa Glaucoma Visual Field

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Glaucoma

Glaucoma Patients with visual field defects

No interventions assigned to this group

Retinitis Pigmentosa

Retinitis Pigmentosa Patients with visual field defects

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Age 18-75
2. Sign on informed consent
3. Papillary response to light.
4. Groups of : Normal , Glaucoma patients with early glaucoma damage on HVF (nasal step ect. ), Glaucoma patients with advanced glaucoma damage on HVF (arcuate , tubular vision ) and RP patients (Early VF damage , ring scotoma ) .
5. Refractive correction up to -3.5 D.

Exclusion Criteria

1. Cloudy corneas.
2. Surgical intraocular ophthalmic procedure within the past 30 days.
3. Nonreactive pupils.
4. Synechia of the iris to the lens after surgery or inflammation .
5. Neovascularization.
6. Iris coloboma.
7. Sphincter damage due to ischemia or trauma (tears of sphincter or diffuse damage to muscle).
8. Sphincter damage due to high intraocular pressure .
9. Iris tumor or cyst .
10. Ectropion uvea .
11. Adie's pupil .
12. Optic neuropathy with the potential for producing a positive RAPD (Relative Afferent Pupillary Defect ).
13. Chronic use of myotics or mydriatics.
14. Systemic Medication which affect on papillary response .
15. Any condition preventing accurate measurement or examination of the pupils.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tel Aviv University, Claire and Amedee Maratier Institute

UNKNOWN

Sponsor Role collaborator

Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Dr. Ygal Rotenstreich

Director, Electrophysiology Clinic, Goldschleger Eye Institute

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ygal Rotenstreich, MD

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Locations

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Sheba Medical Center

Tel Litwinsky, Israel, Israel

Site Status

Countries

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Israel

References

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Yoshitomi T, Matsui T, Tanakadate A, Ishikawa S. Comparison of threshold visual perimetry and objective pupil perimetry in clinical patients. J Neuroophthalmol. 1999 Jun;19(2):89-99.

Reference Type BACKGROUND
PMID: 10380129 (View on PubMed)

Kalaboukhova L, Fridhammar V, Lindblom B. Relative afferent pupillary defect in glaucoma: a pupillometric study. Acta Ophthalmol Scand. 2007 Aug;85(5):519-25. doi: 10.1111/j.1600-0420.2006.00863.x. Epub 2007 Jun 15.

Reference Type BACKGROUND
PMID: 17573859 (View on PubMed)

Kardon RH. Pupil perimetry. Curr Opin Ophthalmol. 1992 Oct;3(5):565-70. doi: 10.1097/00055735-199210000-00002.

Reference Type BACKGROUND
PMID: 10147922 (View on PubMed)

Kardon RH, Kirkali PA, Thompson HS. Automated pupil perimetry. Pupil field mapping in patients and normal subjects. Ophthalmology. 1991 Apr;98(4):485-95; discussion 495-6. doi: 10.1016/s0161-6420(91)32267-x.

Reference Type BACKGROUND
PMID: 2052302 (View on PubMed)

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 DERIVED
PMID: 23482470 (View on PubMed)

Other Identifiers

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SHEBA-09-6958-AS-CTIL

Identifier Type: -

Identifier Source: org_study_id