Status:

COMPLETED

Analysis of the Diagnostic Performance of LacryDiag, a New Analyzer of the Ocular Surface in the Dry Eye

Lead Sponsor:

Centre Hospitalier Universitaire de Saint Etienne

Conditions:

Dry Eye

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

LacryDiag is a new Conformity European (CE) marked diagnostic imaging device devoted to the analysis of the ocular surface. It is an "all in one" device that provides 4 data: non-invasive break-up tim...

Detailed Description

The primary purpose of this study is to compare the value of Break-Up-Time (BUT) between Non-Invasive Break-Up-Time (NIBUT) measured by LacryDiag and Standard Break-Up-Time (SBUT) measured by usual pr...

Eligibility Criteria

Inclusion

  • Affiliates or beneficiaries of social security scheme
  • With Dry eye of any cause, diagnosed with conventional means
  • Signed informed consent

Exclusion

  • Major blepharospasm
  • Serious illness preventing participation according to investigator
  • Allergy to fluorescein
  • Pregnant or / and breastfeeding women
  • Under guardianship, curatorship or safeguard of justice
  • Unable to express their consent
  • Person in emergency situation

Key Trial Info

Start Date :

November 14 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 27 2020

Estimated Enrollment :

80 Patients enrolled

Trial Details

Trial ID

NCT04093037

Start Date

November 14 2019

End Date

August 27 2020

Last Update

September 9 2020

Active Locations (1)

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Chu Saint-Etienne

Saint-Etienne, France