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Completed

NCT Number: NCT04093037

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

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.

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Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Saint-Etienne

Saint-Etienne, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: LacryDiag, Complete diagnosis of dry eyes

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).

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.

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.

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.

Primary outcomes

  1. Break-Up-Time (BUT)

    Time frame: Day: 1

    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 outcomes

  1. Standard Break-Up Time (SBUT)

    Time frame: Day: 1

    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).

  2. MicroInstillation Break-Up Time (MIBUT)

    Time frame: Day: 1

    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).

  3. Tear Meniscus (TM) height and Schirmer test

    Time frame: Day: 1

    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.

  4. Percentage loss of Meibomian Gland.

    Time frame: Day: 1

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

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

    Time frame: Day: 1

    Correlation between measure thickness (in nanometer) and regularity of lacrimal film (type).

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study 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

Acronym: LACRYMOSA

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 17, 2019
Registry last updated
Sep 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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