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

NCT04093037 | Completed

• 2 other identifiers: 18CH1152018-A02257-48
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

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)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Standard Break-Up Time (SBUT)

  Day: 1

• MicroInstillation Break-Up Time (MIBUT)

  Day: 1

• Tear Meniscus (TM) height and Schirmer test

  Day: 1

• Percentage loss of Meibomian Gland.

  Day: 1

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

  Day: 1

Study Arms (1)

Patient with dry eye disease

EXPERIMENTAL

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); 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

Interventions

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

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.

Also known as: LacryDiag, Complete diagnosis of dry eyes

Patient with dry eye disease

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

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).

Patient with dry eye disease

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

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

Patient with dry eye disease

Time #4: Schirmer test DIAGNOSTIC_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.

Patient with dry eye disease

Satisfaction questionnaire to the patient DIAGNOSTIC_TEST

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

Patient with dry eye disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

Chu Saint-Etienne

Saint-Etienne, France

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Gilles THURET, MD PhD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: September 16, 2019
• First Posted: September 17, 2019
• Study Start: November 14, 2019
• Primary Completion: August 27, 2020
• Study Completion: August 27, 2020
• Last Updated: September 9, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)