Evaluation of Objective Perimetry Using Pupillometer | NCT01021982

Studies
Evaluation of Objective Perimetry Using Pupillometer

NCT01021982

Sponsor

Sheba Medical Center

Status

Completed

Last Update Posted

Nov 19, 2014Estimated

Enrollment

60Actual

Phase

Not provided

Conditions

Retinitis Pigmentosa
Glaucoma
Visual Field

Interventions

Not provided

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2009

Primary Completion Date

Jan 2013Actual

Completion Date

Jan 2013Actual

First Submitted Date

Nov 29, 2009

First Submission Date that Met QC Criteria

Nov 29, 2009

First Posted Date

Dec 1, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 18, 2014

Last Update Posted Date

Nov 19, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Ygal Rotenstreich, Director, Electrophysiology Clinic, Goldschleger Eye Institute, Sheba Medical CenterPrincipal Investigator

Lead Sponsor

Sheba Medical CenterOTHER_GOV

Collaborators

Name	Class
Tel Aviv University, Claire and Amedee Maratier Institute	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Glaucoma		Glaucoma Patients with visual field defects
Retinitis Pigmentosa		Retinitis Pigmentosa Patients with visual field defects

Interventions

Not provided

Measure	Description	Time Frame
PLR response amplitude and latency		Not defined yet

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18-75
Sign on informed consent
Papillary response to light.
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 ) .
Refractive correction up to -3.5 D.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

primary care clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ygal Rotenstreich, MD	Sheba Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sheba Medical Center		Tel Litwinsky	Israel	52621	Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
10380129	Background	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.
17573859	Background	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.

ID	Term
D015785	Eye Diseases, Hereditary
D005128	Eye Diseases
D058499	Retinal Dystrophies
D012162	Retinal Degeneration