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

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 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.

Conditions

• Dry Eye

Interventions

DIAGNOSTIC_TEST

Time #1: Non Invasive Break-Up Time (NIBUT)

A LacryDiag examination without dye will be realized. All measurements are made without contact. It's calculates the Non Invasive Break-Up Time (NIBUT), Tear Meniscus (TM) height (in millimeters) and number of Meibomian Gland. These are different pictures taken with LacryDiag and analyzed.

DIAGNOSTIC_TEST

Time #2: MicroInstillation Break-Up Time (MIBUT) + Oxford score

The MicroInstillation of fluorescein Break-Up Time (MIBUT) will be calculated by manual MIBUT and LacryDiag MIBUT. The Oxford score will be calculated. It's used to clinically determine the severity of dry eyes with minimum score at 0 (none) and maximum score at 5 (very severity).

DIAGNOSTIC_TEST

Time #3: Standard Break-Up Time (SBUT)

The Standard Break-Up Time (SBUT) with fluorescein macroinstillation will be calculated by manual SBUT and LacryDiag SBUT.

DIAGNOSTIC_TEST

Time #4: Schirmer test

The Schirmer test will be performed. It consists of applying the end of a small strip of blotting paper behind the lower eyelid and examining the strip after 5 minutes.

DIAGNOSTIC_TEST

Satisfaction questionnaire to the patient

A satisfaction questionnaire to the patient will be completed at the end of the participation at the study.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne

  lead OTHER

Principal Investigators

• Gilles THURET, MD PhD · CHU SAINT-ETIENNE

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-11-14

Primary Completion

2020-08-27

Completion

2020-08-27

Countries

• France

Study Locations