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

Completed

• Conditions: Eye Diseases
• Interventions: Diagnostic Test: EYEPRIM

• Registration Number: NCT06255301
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2024-01-09
• Study First Submitted: 2024-02-02
• Study First Submitted QC: 2024-02-05
• Study First Posted: 2024-02-13
• Primary Completion: 2024-03-21
• Study Completion: 2024-03-21
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-23
• Last Update Posted: 2024-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
limbal stem cell deficiency	EYEPRIM	50 patients with limbal stem cell deficiency will be included.
Control group	EYEPRIM	150 patients with eye diseases other than dry eye syndrome or limbal stem cell deficiency will be included.
dry eye syndrome	EYEPRIM	100 patients with dry eye syndrome will be included.

Primary Outcome Measures

Name	Time	Method
Ocular surface impression cytology collected from patients suffering from dry eye syndrome, limbal stem cell deficiency or other pathologies (control).	day one	Collection of cells from the ocular surface by performing a cytological imprint of the ocular surface

Trial Locations

Locations (1)

CHU Saint-Etienne; 🇫🇷 Saint-Étienne, France