Physiological Upper Eyelid Laxity | NCT03439644

Studies
Physiological Upper Eyelid Laxity

NCT03439644

Sponsor

Poitiers University Hospital

Status

Completed

Last Update Posted

Feb 20, 2018Actual

Enrollment

280Actual

Phase

Not Applicable

Conditions

Eyelid Laxity

Interventions

Measurement of the upper eyelid laxity

Countries

France

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

Feb 2018

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

Oct 25, 2017Actual

Primary Completion Date

Nov 27, 2017Actual

Completion Date

Nov 27, 2017Actual

First Submitted Date

Feb 8, 2018

First Submission Date that Met QC Criteria

Feb 19, 2018

First Posted Date

Feb 20, 2018Actual

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

Feb 19, 2018

Last Update Posted Date

Feb 20, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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

This is a prospective, single-center study in normal subjects aged 20 to 89 years.

The objective was to describe upper eyelid laxity by age group (20/29 years old, 30/39 years old, 40/49 years old, 50/59 years old, 60/69 years old, 70/79 years old and 80/89 years old) measured with the method of McNab and studying it according to her customary side of sleep. In addition, we evaluated a method for measuring tarsal laxity.

Detailed Description

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

280Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Measurement of the upper eyelid laxity	Other	Measurement using a soft slider of the distance between our 2 marks The difference obtained between the measurement and the initial 10 millimeters corresponds to the tarsal laxity.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evolution of upper eyelid laxity	Comparison of upper right and left palpebral laxity values in millimeters between different age groups	10 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

20 to 89 years
be free
be able to give informed consent

Exclusion Criteria:

History of facial paralysis, upper palpebral trauma or palpebral surgery
History of sleep apnea syndrome
Impossibility to give consent
Pregnant or lactating women
Persons enjoying enhanced protection and persons deprived of their liberty by a judicial or administrative decision

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

89 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Roxane FLAUSSE	Poitiers University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU DE Poitiers		Poitiers			France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided