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NCT06255301 Clinical Trial

Collection of Ocular Surface Impressions Cytology of the Living Eye From Patients With Dry Eyes or Limbal Stem Cell Deficiency.

Eye Diseases Clinical Trial

— ESSO  

Official title:
Collection of Ocular Surface Impressions Cytology of the Living Eye From Patients With Dry Eyes or Limbal Stem Cell Deficiency.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06255301
Other study ID # 19CH218
Secondary ID 2020-A00139-30
Status Completed
Phase
First received
Last updated
Start date January 9, 2024
Est. completion date March 21, 2024

Study information
Verified date April 2024
Source Centre Hospitalier Universitaire de Saint Etienne
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In order to develop innovative biomarkers for the diagnosis of two ocular surface pathologies, Dry Syndrome (DS) and Limbic Stem Cell Deficiency (LSCD), human cells from the ocular surface will be collected in order to test these biomarkers ex vivo.

Description:

To collect them, cytological fingerprints of the ocular surface are made using filter paper applied to the surface using a commercially available EC (European Conformity)-marked medical device, called EYEPRIM.

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date March 21, 2024
Est. primary completion date March 21, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patient affiliated or entitled to a social security scheme - Age 18 years or older - Presenting a Dry Syndrome, a limbic stem cell deficiency (clinical diagnosis) or another pathology (control). - Signature of Consent Exclusion Criteria: - Major blepharospasm making examination impossible - Pregnant women - Breastfeeding women - Protected Persons

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• EYEPRIM
Collection of conjunctival impressions using the EC(European Conformity )-marked EYEPRIM device . This device enables cells to be collected the superficial ocular surface cells by applying a membrane for few seconds to the ocular surface.

Locations
Country Name City State
France CHU Saint-Etienne Saint-Étienne

Sponsors (2)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Saint Etienne Laboratoire Biologie, Ingénierie et Imagerie de la Greffe de Cornée (BiiGC)

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Ocular surface impression cytology collected from patients suffering from dry eye syndrome, limbal stem cell deficiency or other pathologies (control). Collection of cells from the ocular surface by performing a cytological imprint of the ocular surface day one
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