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

Analysis of the Diagnostic Performance of LacryDiag, a New "All-in-one" Non-contact Analyzer of the Ocular Surface in the Dry Eye. Study LACRYMOSA

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye
• Intervention / Treatment: Diagnostic test: Time #1: Non Invasive Break-Up Time (NIBUT); Diagnostic test: Time #2: MicroInstillation Break-Up Time (MIBUT) + Oxford score; Diagnostic test: Time #3: Standard Break-Up Time (SBUT); Diagnostic test: Time #4: Schirmer test; Diagnostic test: Satisfaction questionnaire to the patient

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint-Étienne, France
    • Chu Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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

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.; Other Names: LacryDiag; Complete diagnosis of dry eyes; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Break-Up-Time (BUT)	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).	Day: 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Standard Break-Up Time (SBUT)	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).	Day: 1
MicroInstillation Break-Up Time (MIBUT)	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).	Day: 1
Tear Meniscus (TM) height and Schirmer test	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.	Day: 1
Percentage loss of Meibomian Gland.	Measured by time#1: Non Invasive Break-Up Time (NIBUT).	Day: 1
Thickness (in nanometer) and regularity of lacrimal film (type)	Correlation between measure thickness (in nanometer) and regularity of lacrimal film (type). Measured by time#1: Non Invasive Break-Up Time (NIBUT).	Day: 1

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2019
• Primary Completion (Actual): August 27, 2020
• Study Completion (Actual): August 27, 2020

Study Registration Dates

• First Submitted: September 16, 2019
• First Submitted That Met QC Criteria: September 16, 2019
• First Posted (Actual): September 17, 2019

Study Record Updates

• Last Update Posted (Actual): September 9, 2020
• Last Update Submitted That Met QC Criteria: September 7, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Dry eye; Fluorescein; Schirmer test; LacryDiag; Break-Up Time (BUT); Lacrimal film; Oxford score; Meibomian Gland; Tear Meniscus (TM); Non Invasive Break-Up Time (NIBUT)
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: 18CH115; 2018-A02257-48 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No