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Physiological Upper Eyelid Laxity (LAX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03439644
Recruitment Status : Completed
First Posted : February 20, 2018
Last Update Posted : February 20, 2018
Sponsor:
Information provided by (Responsible Party):
Poitiers University Hospital

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.


Condition or disease Intervention/treatment Phase
Eyelid Laxity Other: Measurement of the upper eyelid laxity Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 280 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Physiological Upper Eyelid Laxity
Actual Study Start Date : October 25, 2017
Actual Primary Completion Date : November 27, 2017
Actual Study Completion Date : November 27, 2017

Intervention Details:
  • Other: Measurement of the upper eyelid laxity
    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.


Primary Outcome Measures :
  1. Evolution of upper eyelid laxity [ Time Frame: 10 minutes ]
    Comparison of upper right and left palpebral laxity values in millimeters between different age groups



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03439644


Locations
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France
CHU DE Poitiers
Poitiers, France
Sponsors and Collaborators
Poitiers University Hospital
Investigators
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Principal Investigator: Roxane FLAUSSE Poitiers University Hospital
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Responsible Party: Poitiers University Hospital
ClinicalTrials.gov Identifier: NCT03439644    
Other Study ID Numbers: LAX
First Posted: February 20, 2018    Key Record Dates
Last Update Posted: February 20, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No