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The objective of this observational study is to develop new tools to assess primary Sjögren's syndrome (pSS) symptoms and to measure the severity of eye involvement in these patients.
All clinical trials evaluating the efficacy of immunomodulatory drugs in pSS are negative. This could be due to a lack of sensitivity of the outcome measures used so far to define the response. In this study, investigator will evaluate the feasability, tolerability, and performance of new tools to assess disease evolution:
Patients with a diagnosis of pSS will be included in the study, will undergo detailed ophtalmologic examination, and will then use a webapp, installed on their smartphone, to score their symptoms everyday during 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pSS cohort | Patients with pSS included in the study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ecological symptom measurements using a webapp | Other | A webapp will be installed on the patients' smartphone, which will be used to collect everyday the symptoms of the patients (ESSPRI score) |
| Measure | Description | Time Frame |
|---|---|---|
| Variability in the intensity of patient-reported symptoms | Variability over time (day-to-day assessment) of the ESSPRI score (dispersion of the values compared to the mean) | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability of the daily use of a webapp to measure the symptoms | Score Questionnaire SUS - System Usability Scale. The SUS ranges from 0 to 100, with values above 68 considered as above average. | Month 3 |
| Interferometry |
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Inclusion Criteria:
Exclusion Criteria:
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Consecutive pSS patients seen in Rheumatology
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de BREST | Brest | 29200 | France |
All collected data that underlie results in a publication
Data will be available beginning after publication of result and ending three years maximum following the last visit of last patient
Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.
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| ID | Term |
|---|---|
| D008857 | Microscopy, Interference |
| ID | Term |
|---|---|
| D008853 | Microscopy |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Serum, saliva, cells
| Interferometry | Diagnostic Test | Evaluation of the mebomian function using the LipiView methodology |
|
Measure of mebomian function using the LipiView technology
| 3 months |
| Automated eye surface coloration measurement | Development of an automated method using deep image mining on recorded videos | 3 months |
| D007368 |
| Interferometry |
| D008919 | Investigative Techniques |