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

Dry Eye Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04093037
• Other study ID #: 18CH115
• Secondary ID: 2018-A02257-48
• Status: Completed
• Phase: N/A
• Start date: November 14, 2019
• Est. completion date: August 27, 2020

Study information

• Verified date: September 2020
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 27, 2020
• Est. primary completion date: August 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

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

Locations

Country	Name	City	State
France	Chu Saint-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Percentage loss of Meibomian Gland.	Measured by time#1: Non Invasive Break-Up Time (NIBUT).	Day: 1
Secondary	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