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

Centre Hospitalier Universitaire de Saint Etienne

Status: Completed

Conditions: Dry Eye

Treatments: Diagnostic Test: Time #2: MicroInstillation Break-Up Time (MIBUT) + Oxford score; Diagnostic Test: Time #3: Standard Break-Up Time (SBUT); Diagnostic Test: Time #1: Non Invasive Break-Up Time (NIBUT); Diagnostic Test: Satisfaction questionnaire to the patient; Diagnostic Test: Time #4: Schirmer test

Study type: Interventional

Funder types: Other

Identifiers

NCT04093037

2018-A02257-48 (Other Identifier)

18CH115

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

Patient with dry eye disease

Experimental group

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

Treatment:

Diagnostic Test: Satisfaction questionnaire to the patient

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

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

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

Diagnostic Test: Time #4: Schirmer test