Primary Sjögren Syndrome
Conditions
Brief summary
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.
Detailed description
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: * investigator will develop a webapp to measure the intensity of the symptoms at home on a daily basis (ecological assessment) * investigator will evaluate new ophthalmologic procedures, already used in other conditions but never in pSS, which assess the severity of eye involvement in the disease * investigator will develop an automated method to score the severity of ocular surface lesions in the disease. 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.
Interventions
OTHEREcological symptom measurements using a webapp
A webapp will be installed on the patients' smartphone, which will be used to collect everyday the symptoms of the patients (ESSPRI score)
DIAGNOSTIC_TESTInterferometry
Evaluation of the mebomian function using the LipiView methodology
Sponsors
University Hospital, Brest
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* diagnosis of pSS according to ACR/EULAR classification criteria
Exclusion criteria
* patient does not possess a smartphone with web connection * patient unable to sign an informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Variability in the intensity of patient-reported symptoms | 3 months | Variability over time (day-to-day assessment) of the ESSPRI score (dispersion of the values compared to the mean) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tolerability of the daily use of a webapp to measure the symptoms | Month 3 | Score Questionnaire SUS - System Usability Scale. The SUS ranges from 0 to 100, with values above 68 considered as above average. |
| Interferometry | 3 months | Measure of mebomian function using the LipiView technology |
| Automated eye surface coloration measurement | 3 months | Development of an automated method using deep image mining on recorded videos |
Countries
France
Outcome results
None listed