- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04235400
Multimodal Screening of Dry Eye Disease (MAOS-S)
Multimodal Analysis of Ocular Surface for Screening Dry Eye Disease
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Marc LABETOULLE, Pr
- Phone Number: 33 1 45 21 36 90
- Email: marc.labetoulle@aphp.fr
Study Contact Backup
- Name: Anne-Laurence BEST, Dr
- Email: bestanlo@hotmail.com
Study Locations
-
-
Val De Marne
-
Le Kremlin-Bicêtre, Val De Marne, France, 94275
- Recruiting
- Opthtalmology Departement, Bicêtre Hospital
-
Contact:
- Marc LABETOULLE, Pr
- Phone Number: 33 1 45 21 36 90
- Email: marc.labetoulle@aphp.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
patient with dry eye disease
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
at the end of the study (1year)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ocular Surface Disease Index (OSDI) questionnaire results
Time Frame: at day 1
|
to assess the symptoms of ocular dryness
|
at day 1
|
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
|
at day 1
|
Tear meniscus height
Time Frame: at day 1
|
with the LACRYDIAG device
|
at day 1
|
Results of the tears interferometry with the LACRYDIAG device
Time Frame: at day 1
|
at day 1
|
|
Results of the tears interferometry with the LIPIVIEW device
Time Frame: at day 1
|
at day 1
|
|
Results of the meibography with the LIPIVIEW device
Time Frame: at day 1
|
at day 1
|
|
Thickness of the lipidic layer measured with LIPIVIEW device
Time Frame: at day 1
|
at day 1
|
|
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
|
at day 1
|
Quality of the corneal epithelium (after fluorescein instillation, Oxford scale)
Time Frame: at day 1
|
at day 1
|
|
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
|
at day 1
|
Collaborators and Investigators
Investigators
- Principal Investigator: Marc LABETOULLE, Pr, Assistance Publique - Hôpitaux de Paris
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- APHP191122
- 2019-A03086-51 (Other Identifier: ID-RCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dry Eye Disease
-
Bausch & Lomb IncorporatedCompletedDry Eye Disease (DED)United States
-
Gordon Schanzlin New VisionCompletedDry Eye | Dry Eye Disease | Evaporative Dry Eye | Kerato Conjunctivitis Sicca | Evaporative Dry Eye Disease | Dry Eye, EvaporativeUnited States
-
Laboratorios Sophia S.A de C.V.Not yet recruitingOcular Surface Disease | Dry Eye Disease | Dry Eye Sensation
-
AllerganCompletedDry Eye Syndrome | Dry Eye DiseaseUnited States
-
Senju Pharmaceutical Co., Ltd.CompletedDry Eye Syndrome | Dry Eye DiseaseUnited States
-
LantibioRiver Plate Biotechnology, Inc.; Rx Development Resources, LLCCompletedSafety and Efficacy Assessment of Vismed® (Sodium Hyaluronate) for the Treatment of Dry Eye SyndromeDry Eye DiseaseUnited States
-
Fundación Oftalmológica Los AndesAlcon ResearchNot yet recruitingCataract | Dry Eye Syndrome | Dry Eye Disease | Phacoemulsification | Evaporative Dry Eye
-
Vienna Institute for Research in Ocular SurgeryTerminated
-
Novaliq GmbHCompletedDry Eye Disease (DED)United States
-
Novaliq GmbHCompletedDry Eye Disease (DED)United States
Clinical Trials on No Dye BreakUp Time
-
Massachusetts General HospitalShriners Hospitals for ChildrenUnknownBurn ScarsUnited States
-
WellSpan HealthCompletedHysterectomy | CystoscopyUnited States
-
University of California, San DiegoCompleted
-
Heidelberg UniversityUnknownColorectal Liver MetastasesGermany
-
University of MichiganCompleted
-
Merz Pharmaceuticals GmbHMerz North America, Inc.Completed
-
University of Alabama at BirminghamActive, not recruitingDental Implant | Ridge Deficency | Bone Graft; Complications, Infection or InflammationUnited States
-
University of California, DavisCompleted
-
Columbia UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); University...Completed
-
Avera McKennan Hospital & University Health CenterVintek, LLCCompleted