Dry Eye DiseaseMAOS-SNCT04235400
Multimodal Screening of Dry Eye Disease
An observational study of Dry Eye Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease
- What is being tested?
- No Dye BreakUp Time
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 28 Jan 2021to Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Major patients consulting for dry eyes or requiring dry eye screening
Who may be able to join
- adult patient (age >18 yo),
- known allergy to topical fluorescein
- Patient informed of the study who gave it's non-opposition to participate
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Anne-Laurence BEST, Dr contact
France1 site, 1 recruiting
- Recruiting
Opthtalmology Departement, Bicêtre Hospital
Le Kremlin-Bicêtre, Val De Marne, 94275
Marc LABETOULLE, Pr, 33 1 45 21 36 90, marc.labetoulle@aphp.fr
About this study
Official title: Multimodal Analysis of Ocular Surface for Screening Dry Eye Disease
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:
- 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
- Dry Eye Disease
- Being tested
- No Dye BreakUp Time
- Keywords
- dry eye, TBUT, NIBUT
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Dye BreakUp TimeDiagnostic 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).
| Study group | Role | What they receive |
|---|---|---|
| patient with dry eye disease | Not described Receives: Diagnostic Test: No Dye BreakUp Time |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: at the end of the study (1year)
Secondary outcomes (10)
Ocular Surface Disease Index (OSDI) questionnaire results
to assess the symptoms of ocular dryness
Measured: at day 1
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
Measured: at day 1
Tear meniscus height
with the LACRYDIAG device
Measured: at day 1
Results of the tears interferometry with the LACRYDIAG device
Measured: at day 1
Results of the tears interferometry with the LIPIVIEW device
Measured: at day 1
Results of the meibography with the LIPIVIEW device
Measured: at day 1
Thickness of the lipidic layer measured with LIPIVIEW device
Measured: at day 1
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
Measured: at day 1
Quality of the corneal epithelium (after fluorescein instillation, Oxford scale)
Measured: at day 1
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
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2020
- Study start28 Jan 2021
- Primary completionJan 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc LABETOULLE, Pr, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04235400
- Sponsor's protocol ID
- APHP191122
- Other IDs
- 2019-A03086-51
- Acronym
- MAOS-S
- Status last verified
- Sep 2022
- First submitted
- 17 Jan 2020
- Last updated
- 7 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Analysis of Ocular Surface for Screening Dry Eye Disease
- ClinicalTrials.gov ID
- NCT04235400
- Acronym / sponsor ID
- MAOS-S / APHP191122
- Conditions
- Dry Eye Disease
- Keywords
- dry eye, TBUT, NIBUT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 28 Jan 2021 (actual)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 21 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
To date, there are a limited numbers of tests available for screening ocular dryness:
- 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient with dry eye disease | – | Diagnostic Test: No Dye BreakUp Time |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Major patients consulting for dry eyes or requiring dry eye screening
Key inclusion criteria (3 listed)
- adult patient (age >18 yo),
- known allergy to topical fluorescein
- Patient informed of the study who gave it's non-opposition to participate
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Dye BreakUp TimeMeasurement 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). | Diagnostic test | patient with dry eye disease |
Primary outcome
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)
10 secondary outcomes
Ocular Surface Disease Index (OSDI) questionnaire results
Time frame: 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
Tear meniscus height
Time frame: at day 1
Results of the tears interferometry with the LACRYDIAG device
Time frame: at day 1
Results of the tears interferometry with the LIPIVIEW device
Time frame: at day 1
Results of the meibography with the LIPIVIEW device
Time frame: at day 1
Thickness of the lipidic layer measured with LIPIVIEW device
Time frame: at day 1
Tear osmolarity
Time frame: at day 1
Quality of the corneal epithelium (after fluorescein instillation, Oxford scale)
Time frame: at day 1
Tear's production measured by Schirmer I test
Time frame: at day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne-Laurence BEST, Dr contact
Marc LABETOULLE, Pr principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dry Eye Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marc LABETOULLE, Pr (33 1 45 21 36 90, marc.labetoulle@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
results of the NDBUT and FBUT (time frame: at the end of the study (1year)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2022.