Evaluation of Objective Perimetry Using Chromatic Multifo... | NCT02014389

Studies
Evaluation of Objective Perimetry Using Chromatic Multifocal Pupillometer

NCT02014389

Sponsor

Sheba Medical Center

Status

Recruiting

Last Update Posted

Apr 25, 2024Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Retinal Dystrophies
Retinitis Pigmentosa
Glaucoma

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

Apr 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2013Actual

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Dec 12, 2013

First Submission Date that Met QC Criteria

Dec 17, 2013

First Posted Date

Dec 18, 2013Estimated

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

Apr 24, 2024

Last Update Posted Date

Apr 25, 2024Actual

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 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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy subjects		Healthy subjects will be used as control group
Patients		Patients with Glaucoma , Patients with retinal dystrophy

Interventions

Not provided

Measure	Description	Time Frame
PLR response amplitude and latency		single visit

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Cloudy corneas.
Surgical intraocular ophthalmic procedure within the past 30 days.
No reactive pupils.
Synechia of the iris to the lens after surgery or inflammation.
Neovascularization.
Axenfeld-Rieger Syndrome.
Iris atrophy (ICE syndrome).
Iris coloboma.
Sphincter damage due to ischemia.
Sphincter damage due to trauma (tears of sphincter or diffuse damage to muscle).
Sphincter damage due to Herpes Zoster Uveitis.
Sphincter damage due to high intraocular pressure.
Iris tumor or cyst.
Ectropion uvae.
Adie's pupil.
Third nerve aberrant regeneration of the iris sphincter.
RP patients with Optic neuropathy with the potential of producing a positive RAPD (Relative Afferent Pupillary Defect).
Chronic use of myotics or mydriatics.
Systemic medication that have affect on pupillary reflex .
Any condition preventing accurate measurement or examination of the pupil.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Two Groups: 1. Control, 2. Patients - Glaucoma patients with early damage (nasal step) of Humphrey visual field (HVF), Glaucoma patients with advanced damage of HVF (arcuate , tubular vision) and retinal dystrophy patientsl

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ygal Rotenstreich, MD	Contact	972547898137		Ygal.Rotenstreich@sheba.health.gov.il

Overall Officials

Not provided

Locations

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

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23482470	Background	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.

ID	Term
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases
D015785	Eye Diseases, Hereditary

ID	Term
D058499	Retinal Dystrophies
D012174	Retinitis Pigmentosa
D005901	Glaucoma