Influence of Hypoxia on Electroretingraphy (ERG) Measurem... | NCT01246024

Studies
Influence of Hypoxia on Electroretingraphy (ERG) Measurements

NCT01246024

Sponsor

University Hospital Tuebingen

Status

Unknown status

Last Update Posted

Nov 23, 2010Estimated

Enrollment

30Estimated

Phase

Not Applicable

Conditions

ERG Under Hypoxia

Interventions

Countries

Germany

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 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2011

Primary Completion Date

Apr 2011Estimated

Completion Date

Apr 2013Estimated

First Submitted Date

Nov 22, 2010

First Submission Date that Met QC Criteria

Nov 22, 2010

First Posted Date

Nov 23, 2010Estimated

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 22, 2010

Last Update Posted Date

Nov 23, 2010Estimated

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

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Label	Type	Description	Intervention Names
Hypoxia	Experimental		Device: ERG

Name	Type	Description	Arm Group Labels	Other Names
ERG	Device	scotopic and photopic ERG	Hypoxia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Electroretingraphy Measurements		01.02.2011-01.06.2011

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy subjects

Exclusion Criteria:

under 18 and over 80 years, respiratory diseases, cataracta and corneal hazes, myopia more than 6 dpt, hyperopia more than 3 dpt, allergy for any topical anesthetics in ophthalmology, photic epilepsy, asthma bronchiale.

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Florian Gekeler, Prof. Dr. med.	Contact	+4970712987461		fgekeler@googlemail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre for Ophthalmology		Tübingen		D-72076	Germany