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

Primary Purpose

Dry Eye

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

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

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

About this trial

This is an interventional diagnostic trial for Dry Eye focused on measuring Dry eye, LacryDiag, Fluorescein, Break-Up Time (BUT), Schirmer test, Lacrimal film, Oxford score, Meibomian Gland, Tear Meniscus (TM), Non Invasive Break-Up Time (NIBUT)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Chu Saint-Etienne

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patient with dry eye disease

Arm Description

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).

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).

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.

Percentage loss of Meibomian Gland.

Measured by time#1: Non Invasive Break-Up Time (NIBUT).

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).

Full Information

NCT ID

NCT04093037

First Posted

September 16, 2019

Last Updated

September 7, 2020

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

1. Study Identification

Unique Protocol Identification Number

NCT04093037

Brief Title

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

Acronym

LACRYMOSA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

November 14, 2019 (Actual)

Primary Completion Date

August 27, 2020 (Actual)

Study Completion Date

August 27, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Universitaire de Saint Etienne

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dry Eye

Keywords

Dry eye, LacryDiag, Fluorescein, Break-Up Time (BUT), Schirmer test, Lacrimal film, Oxford score, Meibomian Gland, Tear Meniscus (TM), Non Invasive Break-Up Time (NIBUT)

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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)

Masking

None (Open Label)

Allocation

N/A

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Patient with dry eye disease

Arm Type

Experimental

Arm Description

Intervention Type

Diagnostic Test

Intervention Name(s)

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

Other Intervention Name(s)

LacryDiag, Complete diagnosis of dry eyes

Intervention Description

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.

Intervention Type

Diagnostic Test

Intervention Name(s)

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

Intervention Description

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).

Intervention Type

Diagnostic Test

Intervention Name(s)

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

Intervention Description

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

Intervention Type

Diagnostic Test

Intervention Name(s)

Time #4: Schirmer test

Intervention Description

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.

Intervention Type

Diagnostic Test

Intervention Name(s)

Satisfaction questionnaire to the patient

Intervention Description

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

Primary Outcome Measure Information:

Title

Break-Up-Time (BUT)

Description

Time Frame

Day: 1

Secondary Outcome Measure Information:

Title

Standard Break-Up Time (SBUT)

Description

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).

Time Frame

Day: 1

Title

MicroInstillation Break-Up Time (MIBUT)

Description

Time Frame

Day: 1

Title

Tear Meniscus (TM) height and Schirmer test

Description

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.

Time Frame

Day: 1

Title

Percentage loss of Meibomian Gland.

Description

Measured by time#1: Non Invasive Break-Up Time (NIBUT).

Time Frame

Day: 1

Title

Thickness (in nanometer) and regularity of lacrimal film (type)

Description

Correlation between measure thickness (in nanometer) and regularity of lacrimal film (type). Measured by time#1: Non Invasive Break-Up Time (NIBUT).

Time Frame

Day: 1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gilles THURET, MD PhD

Organizational Affiliation

CHU SAINT-ETIENNE

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chu Saint-Etienne

City

Saint-Étienne

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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