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Multimodal Screening of Dry Eye Disease (MAOS-S)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04235400
Recruitment Status : Not yet recruiting
First Posted : January 21, 2020
Last Update Posted : January 29, 2020
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
Two methods allow to evaluate tear breakup time (BUT): without prior dye instillation (No Dye BreakUp Time NDBUT) or after fluorescein instilation (FBUT). The interconnections between those two values are unknown

Condition or disease Intervention/treatment
Dry Eye Disease Diagnostic Test: No Dye BreakUp Time

Detailed Description:

To date, there are a limited numbers of tests available for screening ocular dryness:

i) assessement of tear production through Schirmer's test (paper strips are inserted into the eye for 5 minutes to measure the production of tears: normal value is superior to 15 mm wetting of the paper after 5 minutes, pathologic if inferior to 5-10 mm) ii) assessment of the ocular surface damage after instillation of fluorescein (presence of punctuate superficial lesions on the corneal and conjunctival epithelium) the with the slit lamp + blue filter iii) assessment of the FBUT (measurement of the tear breakup time after fluorescein dye instillation): normal value is superior to 15 seconds, pathologic value inf inferior to 5-10 seconds iv) assessment of the inflammation of eyelids (with the slit lamp). These diagnostic tests are used in everyday clinical practice, but however the international consensus conference (Dry Eye Workshop II, 2017) clearly recommended that, whenever practicable, some other tests must be carried out to optimize the efficacy the diagnostic procedure of dry eye disease. This is the case for the NDBUT (in opposition to the FBUT which uses fluorescein), the tear meniscus height (TMH) which give an rapid hint on the quantity of tears present on the ocular surface, the measure in real time of the tear osmolarity and, at last, the analysis of the thickness of the tear's layer by interferometry (measurement of the light fringes reflected by the tears when illuminated with polarized light, whereby the complete layer or the lipid layer alone can be evaluated separately depending on the machines used) and of the assessment of the quality of the Meibomian glands (non-contact imaging by infrared illumination).

All these techniques are recommended for the detection and the analysis of the mechanism inducing ocular dryness because they are non-invasive and painless. They also are recommended to be carried out jointly because there is still no single objective criterion that is sufficiently robust to be used alone to make this diagnosis, which is therefore ultimately based on an overall analysis of these various parameters.

Furthermore, the nature of the relationships between these different objective diagnostic tests remains still poorly understood.

One of the least well elucidated points in this respect is the relationship between the FBUT and the NDBUT, the latter having the theoretical advantage of being less subjective (the measurement is made by a medical device that detects the deformation time of a light test pattern projected onto the tear film). This method therefore tends to measure rather the moment when the film becomes thinner (generating the deformation of the test pattern), whereas the measurement of FBUT (i.e. after instillation of fluorescein), is certainly subjective but it measures the real tear break time, which corresponds physiologically to a critical moment (regulated by the blink reflex when sensitivity is normal). A retrospective study, carried out in patients known to suffer from dry eye disease and using many of the same instruments as those to be used in the present study, suggested that the NDBUT is generally longer than the FBUT (with an increasing difference with the values), which could be considered paradoxical (the thinning being expected to precede the complete rupture). This relationship must therefore be studied prospectively to analyze the nature of this difference (correlation?) and its relationship with other markers of dry eye disease.

The level of subjective symptoms and the impact on the quality of life felt by the patient will be recorded in order to explore whether the possible difference between NDBUT and FBUT is correlated with the intensity and/or frequency of the symptoms felt.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Multimodal Analysis of Ocular Surface for Screening Dry Eye Disease
Estimated Study Start Date : February 2020
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Group/Cohort Intervention/treatment
patient with dry eye disease Diagnostic Test: No Dye BreakUp Time
Measurement without dye of the tear meniscus height (TMH) which give an rapid hint on the quantity of tears present on the ocular surface, the measure in real time of the tear osmolarity and, at last, the analysis of the thickness of the tear's layer by interferometry (measurement of the light fringes reflected by the tears when illuminated with polarized light, whereby the complete layer or the lipid layer alone can be evaluated separately depending on the machines used) and of the assessment of the quality of the Meibomian glands (non-contact imaging by infrared illumination).




Primary Outcome Measures :
  1. results of the NDBUT and FBUT [ Time Frame: at the end of the study (1year) ]
    analysis of the interconnections between the measure of the tear breakup time without adjunction of dye and measure obtained after instillation of the dye (fluorescein)


Secondary Outcome Measures :
  1. Ocular Surface Disease Index (OSDI) questionnaire results [ Time Frame: at day 1 ]
    to assess the symptoms of ocular dryness

  2. visual analogic scale (EVA) for the assessment of the impact of the dry eye for the patient [ Time Frame: at day 1 ]
    0 means no impact, 100 means total impact of the disease

  3. Tear meniscus height [ Time Frame: at day 1 ]
    with the LACRYDIAG device

  4. Results of the tears interferometry with the LACRYDIAG device [ Time Frame: at day 1 ]
  5. Results of the tears interferometry with the LIPIVIEW device [ Time Frame: at day 1 ]
  6. Results of the meibography with the LIPIVIEW device [ Time Frame: at day 1 ]
  7. Thickness of the lipidic layer measured with LIPIVIEW device [ Time Frame: at day 1 ]
  8. Tear osmolarity [ Time Frame: at day 1 ]
    normal osmolarity is about 290 milliosmol per liter (mOsm/l). An elevated reading, >313 mOsm/L indicates hyperosmolarity, and thus the loss of homeostasis leading to dry eye disease

  9. Quality of the corneal epithelium (after fluorescein instillation, Oxford scale) [ Time Frame: at day 1 ]
  10. Tear's production measured by Schirmer I test [ Time Frame: at day 1 ]
    normal value is superior to 15 mm wetting of the paper after 5 minutes, pathologic if inferior to 5-10 mm



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Major patients consulting for dry eyes or requiring dry eye screening
Criteria

Inclusion Criteria:

  • adult patient (age >18 yo),
  • known allergy to topical fluorescein
  • Patient informed of the study who gave it's non-opposition to participate

Exclusion Criteria:

  • Ocular surgery (including punctal plugs surgery) within the 3 previous months
  • contact lens wearing within the 3 previous months
  • Patient under guardianship or convicted person
  • pregnant woman

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04235400


Contacts
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Contact: Marc LABETOULLE, Pr 33 1 45 21 36 90 marc.labetoulle@aphp.fr
Contact: Anne-Laurence BEST, Dr bestanlo@hotmail.com

Locations
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France
Opthtalmology Departement, Bicêtre Hospital
Le Kremlin-Bicêtre, Val De Marne, France, 94275
Contact: Marc LABETOULLE, Pr    33 1 45 21 36 90    marc.labetoulle@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Marc LABETOULLE, Pr Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04235400    
Other Study ID Numbers: APHP191122
2019-A03086-51 ( Other Identifier: ID-RCB )
First Posted: January 21, 2020    Key Record Dates
Last Update Posted: January 29, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
dry eye
TBUT
NIBUT
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases