CClinicalTrials.gg
Status unknownNCT04235400MAOS-SUpdated Sep 7, 2022

Multimodal Screening of Dry Eye Disease

An observational study in Dry Eye Disease, sponsored by Assistance Publique - Hôpitaux de Paris. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-07.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

The sponsor has not verified this record recently (last verified Sep 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
60
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Dry Eye Disease

Keywords

  • dry eye
  • TBUT
  • NIBUT
03

In context

Dry Eye Syndromes

1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.

This study's planned enrollment of 60 is below the median of 90 across 171 observational studies indexed under Dry Eye Syndromes.

Browse Dry Eye Syndromes studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,506 studies on the registry; 1,007 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Major patients consulting for dry eyes or requiring dry eye screening

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

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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • patient with dry eye disease

    Diagnostic Test: No Dye BreakUp Time

Interventions

  • Diagnostic testNo 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).

06

What researchers measure

Primary outcomes

  1. results of the NDBUT and FBUT

    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)

    Time frame: at the end of the study (1year)

Secondary outcomes

  1. Ocular Surface Disease Index (OSDI) questionnaire results

    to assess the symptoms of ocular dryness

    Time frame: at day 1

  2. visual analogic scale (EVA) for the assessment of the impact of the dry eye for the patient

    0 means no impact, 100 means total impact of the disease

    Time frame: at day 1

  3. Tear meniscus height

    with the LACRYDIAG device

    Time frame: at day 1

  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

    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

    Time frame: at day 1

  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

    normal value is superior to 15 mm wetting of the paper after 5 minutes, pathologic if inferior to 5-10 mm

    Time frame: at day 1

07

Study locations

1 of 1 sites recruiting
  • Opthtalmology Departement, Bicêtre Hospital
    Le Kremlin-Bicêtre, Val De Marne 94275, France
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 7, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04235400
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Responsible party
Sponsor
First posted
Jan 21, 2020
Start date
Jan 28, 2021
Primary completion
Jan 2023 (estimated)
Completion
Mar 2023 (estimated)
Last update
Sep 7, 2022

Study contacts

Marc LABETOULLE, Pr
Contact
marc.labetoulle@aphp.fr
33 1 45 21 36 90
Anne-Laurence BEST, Dr
Contact
bestanlo@hotmail.com
Marc LABETOULLE, Pr
principal investigator · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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