Three-dimensional Analysis of EMMPRIN on Conjunctival Epithelial Cells Surface in Severe Dry Eye Syndrome (ALTESSE)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Conjunctival Diseases, Dry Eye Syndromes. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Modifications of cell surface markers (including EMMPRIN) were observed in conjunctival epithelial cells during dry eye syndrome ; this study aims to describe the modifications of the repartition of these cell surface markers before and after initiation of a treatment.
Primary outcome measures
- comparison of surface area of cell markers measured on conjunctival epithelial cells, in persons with and without severe eye dryness. [Time frame: baseline]
Eligibility criteria
Patients:
Inclusion criteria
- 18 years and over
- Severe eye dryness (grade 3 or 4) as defined by the International Dry Eye Work Shop (2007): Frequent symptoms, Impregnation of fluorescein at the conjunctival level, marked fluorescein staining at the corneal level, Tear Break Up Time ≤ 5 seconds (fluorescein test) Schirmer's test score without anesthesia ≤ 5mm at 5 minutes
- Patients without eye treatment or patients undergoing long-term stable eye treatment for whom a new treatment is being introduced
Exclusion criteria - Known pregnancy or breastfeeding
Control subjects:
Inclusion criteria
\- 18 years and over
Exclusion criteria
- Wearer of contact lenses
- Topical ocular treatment
- Known pregnancy or breastfeeding
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
France · 1 center
- Fondation Ophtalmologique A de Rothschild — Paris
Identifiers
NCT: NCT03358979 · EGN_2017_15