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

Not Applicable

Completed

• Conditions: Dry Eye
• Interventions: Diagnostic Test: Satisfaction questionnaire to the patient

• Registration Number: NCT04093037
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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 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.

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 practice.

Study Timeline

• Study First Submitted: 2019-09-16
• Study First Submitted QC: 2019-09-16
• Study First Posted: 2019-09-17
• Study Start: 2019-11-14
• Primary Completion: 2020-08-27
• Study Completion: 2020-08-27
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-07
• Last Update Posted: 2020-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patient with dry eye disease	Satisfaction questionnaire to the patient	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

Primary Outcome Measures

Name	Time	Method
Break-Up-Time (BUT)	Day: 1	Comparison of Break-Up-Time (BUT) measured by 2 methods : LacryDiag Non Invasive Break-Up Time (NIBUT) and manual Standard Break-Up Time (SBUT).; Measured in seconds by time#1: Non Invasive Break-Up Time (NIBUT) and time#3: Standard Break-Up Time (SBUT).

Secondary Outcome Measures

Name	Time	Method
Tear Meniscus (TM) height and Schirmer test	Day: 1	Correlation between Tear Meniscus (TM) height (in millimeters) and Schirmer test (in millimeters).; Measured by time#1: Non Invasive Break-Up Time (NIBUT) and time#4: Schirmer test.
Thickness (in nanometer) and regularity of lacrimal film (type)	Day: 1	Correlation between measure thickness (in nanometer) and regularity of lacrimal film (type).; Measured by time#1: Non Invasive Break-Up Time (NIBUT).
Percentage loss of Meibomian Gland.	Day: 1	Measured by time#1: Non Invasive Break-Up Time (NIBUT).
Standard Break-Up Time (SBUT)	Day: 1	Comparison of Standard Break-Up Time (SBUT) between LacryDiag SBUT results and manual SBUT results. Measured in seconds.; Measured by time#3: Standard Break-Up Time (SBUT).
MicroInstillation Break-Up Time (MIBUT)	Day: 1	Comparison of MicroInstillation Break-Up Time (MIBUT) between LacryDiag MIBUT results and manual MIBUT results.; Measured in seconds by time#1: Non Invasive Break-Up Time (NIBUT) and time#2: MicroInstillation Break-Up Time (MIBUT).

Trial Locations

Locations (1)

Chu Saint-Etienne; 🇫🇷 Saint-Étienne, France