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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-14

Study Completion Date

2020-08-27

Brief Summary

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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 time (Non-Invasive Break-Up-Time (NIBUT) without fluorescein eye drop); height of the Tear Meniscus (TM); an infrared image of the meibomian glands; a picture of the lacrimal film by interferometry. it's performance will be compare between in diagnosing dry eye syndrome with the standard clinical evaluation, in 80 patients suffering from dry eye diseases and followed at the consultation of the Ophthalmology department of the University Hospital of Saint-Etienne.

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Detailed Description

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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 practice.

Conditions

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Dry Eye

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

80 patients divided into 4 subgroups according to the value of manual Standard Break-Up-Time (SBUT):

* 0-5 seconds (very dry)
* 5-10 seconds (sec)
* 10-15 seconds (moderately dry)
* 15-20 seconds (normal)

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patient with dry eye disease

Patient with dry eye disease will be included. They will have:

* Time #1: LacryDiag examination without dye
* Time #2: MicroInstillation Break-Up Time (MIBUT) + Oxford score
* Time #3: Standard Break-Up Time (SBUT)
* Time #4: Schirmer test
* Satisfaction questionnaire to the patient

Group Type EXPERIMENTAL