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

Sponsor
Centre Hospitalier Universitaire de Saint Etienne (Other)
Overall Status
Completed
CT.gov ID
NCT04093037
Collaborator
(none)
80
Enrollment
1
Location
1
Arm
9.4
Actual Duration (Months)
8.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • 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
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention 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)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)
Primary Purpose:
Diagnostic
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
Actual Study Start Date :
Nov 14, 2019
Actual Primary Completion Date :
Aug 27, 2020
Actual Study Completion Date :
Aug 27, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Patient with dry eye disease

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)
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

    • Diagnostic Test: 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).

    Diagnostic Test: 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.

    Diagnostic Test: 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.

    Diagnostic Test: Satisfaction questionnaire to the patient
    A satisfaction questionnaire to the patient will be completed at the end of the participation at the study.

    Outcome Measures

    Primary Outcome Measures

    1. Break-Up-Time (BUT) [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 Outcome Measures

    1. Standard Break-Up Time (SBUT) [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) [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 [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. [Day: 1]

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

    5. Thickness (in nanometer) and regularity of lacrimal film (type) [Day: 1]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chu Saint-Etienne Saint-Étienne France

    Sponsors and Collaborators

    • Centre Hospitalier Universitaire de Saint Etienne

    Investigators

    • Principal Investigator: Gilles THURET, MD PhD, CHU SAINT-ETIENNE

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Universitaire de Saint Etienne
    ClinicalTrials.gov Identifier:
    NCT04093037
    Other Study ID Numbers:
    • 18CH115
    • 2018-A02257-48
    First Posted:
    Sep 17, 2019
    Last Update Posted:
    Sep 9, 2020
    Last Verified:
    Sep 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Centre Hospitalier Universitaire de Saint Etienne
    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)
    Additional relevant MeSH terms:
    Dry Eye Syndromes
    Keratoconjunctivitis Sicca

    Study Results

    No Results Posted as of Sep 9, 2020