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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-A02257-48 | Other Identifier | ANSM |
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LacryDiag is a new Conformity European (CE) marked diagnostic imaging device devoted to the analysis of the ocular surface. It is an "all in one" device that provides 4 data: non-invasive break-up time (Non-Invasive Break-Up-Time (NIBUT) without fluorescein eye drop); height of the Tear Meniscus (TM); an infrared image of the meibomian glands; a picture of the lacrimal film by interferometry. it's performance will be compare between in diagnosing dry eye syndrome with the standard clinical evaluation, in 80 patients suffering from dry eye diseases and followed at the consultation of the Ophthalmology department of the University Hospital of Saint-Etienne.
The primary purpose of this study is to compare the value of Break-Up-Time (BUT) between Non-Invasive Break-Up-Time (NIBUT) measured by LacryDiag and Standard Break-Up-Time (SBUT) measured by usual practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient with dry eye disease | Experimental | Patient with dry eye disease will be included. They will have:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Time #1: Non Invasive Break-Up Time (NIBUT) | Diagnostic Test | A LacryDiag examination without dye will be realized. All measurements are made without contact. It's calculates the Non Invasive Break-Up Time (NIBUT), Tear Meniscus (TM) height (in millimeters) and number of Meibomian Gland. These are different pictures taken with LacryDiag and analyzed. |
| Measure | Description | Time Frame |
|---|---|---|
| Break-Up-Time (BUT) | Comparison of Break-Up-Time (BUT) measured by 2 methods : LacryDiag Non Invasive Break-Up Time (NIBUT) and manual Standard Break-Up Time (SBUT). Measured in seconds by time#1: Non Invasive Break-Up Time (NIBUT) and time#3: Standard Break-Up Time (SBUT). | Day: 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Standard Break-Up Time (SBUT) | Comparison of Standard Break-Up Time (SBUT) between LacryDiag SBUT results and manual SBUT results. Measured in seconds. Measured by time#3: Standard Break-Up Time (SBUT). | Day: 1 |
| MicroInstillation Break-Up Time (MIBUT) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gilles THURET, MD PhD | Centre Hospitalier Universitaire de Saint Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Saint-Etienne | Saint-Etienne | France |
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80 patients divided into 4 subgroups according to the value of manual Standard Break-Up-Time (SBUT):
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| Time #2: MicroInstillation Break-Up Time (MIBUT) + Oxford score | Diagnostic Test | The MicroInstillation of fluorescein Break-Up Time (MIBUT) will be calculated by manual MIBUT and LacryDiag MIBUT. The Oxford score will be calculated. It's used to clinically determine the severity of dry eyes with minimum score at 0 (none) and maximum score at 5 (very severity). |
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| Time #3: Standard Break-Up Time (SBUT) | Diagnostic Test | The Standard Break-Up Time (SBUT) with fluorescein macroinstillation will be calculated by manual SBUT and LacryDiag SBUT. |
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| Time #4: Schirmer test | Diagnostic Test | The Schirmer test will be performed. It consists of applying the end of a small strip of blotting paper behind the lower eyelid and examining the strip after 5 minutes. |
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| Satisfaction questionnaire to the patient | Diagnostic Test | A satisfaction questionnaire to the patient will be completed at the end of the participation at the study. |
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Comparison of MicroInstillation Break-Up Time (MIBUT) between LacryDiag MIBUT results and manual MIBUT results. Measured in seconds by time#1: Non Invasive Break-Up Time (NIBUT) and time#2: MicroInstillation Break-Up Time (MIBUT). |
| Day: 1 |
| Tear Meniscus (TM) height and Schirmer test | Correlation between Tear Meniscus (TM) height (in millimeters) and Schirmer test (in millimeters). Measured by time#1: Non Invasive Break-Up Time (NIBUT) and time#4: Schirmer test. | Day: 1 |
| Percentage loss of Meibomian Gland. | Measured by time#1: Non Invasive Break-Up Time (NIBUT). | Day: 1 |
| Thickness (in nanometer) and regularity of lacrimal film (type) | Correlation between measure thickness (in nanometer) and regularity of lacrimal film (type). Measured by time#1: Non Invasive Break-Up Time (NIBUT). | Day: 1 |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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