Retinal Venous Pressure (RVP) in Normals | NCT01732042

Studies
Retinal Venous Pressure (RVP) in Normals

NCT01732042

Sponsor

University Hospital, Basel, Switzerland

Status

Completed

Last Update Posted

Dec 11, 2013Estimated

Enrollment

200Actual

Phase

Not provided

Conditions

Healthy

Interventions

Not provided

Countries

Switzerland

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

Dec 2013

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 2011

Primary Completion Date

Jun 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Oct 24, 2012

First Submission Date that Met QC Criteria

Nov 16, 2012

First Posted Date

Nov 22, 2012Estimated

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

Dec 10, 2013

Last Update Posted Date

Dec 11, 2013Estimated

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

Determinate the standard values of the retinal venous pressure in a cohort of healthy subjects.

Detailed Description

The retinal venous pressure (RVP) is an increasingly important dimension in the clinical assessment of retinal blood flow.

In literature only very few and also divergent data on the retinal venous pressure in healthy volunteers are described. A normal value study will provide us with an up-to-date database.

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

200Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Retinal venous pressure	Quantification of the retinal venous pressure as a standard value in a cohort of healthy volunteers	1 hour

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy

Exclusion Criteria:

eye diseases
systemic diseases
term medication (except contraceptives)
pregnancy
allergies to the ingredients Alcaine, Tropicamide and Phenylephrine

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

healthy volunteers

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Josef Flammer, MD	University of Basel, Dept. of Ophthalmology	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Basel, Dept. of Ophthalmology		Basel		4031	Switzerland