Multimodal Screening of Dry Eye Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-28

Study Completion Date

2023-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Keratometric Tear Breakup Time and Fluorescein Tear Breakup Time

NCT00854906

Dry Eye

COMPLETED

Digital Photography to Evaluate Dry Eye

NCT00073099

Eye Disease

COMPLETED

Impairment of Reading Ability in Dry Eye Patients

NCT01826812

Dry Eye Syndromes

COMPLETED

TearLab Core Validation Study to Establish Referent Values for Dry Eye Disease

NCT00848198

Keratoconjunctivitis Sicca

COMPLETED

Diagnostic Evaluation of the Tear Film

NCT00761917

Dry Eye Syndromes

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dry Eye Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

patient with dry eye disease

No Dye BreakUp Time

Intervention Type DIAGNOSTIC_TEST

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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No