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

NCT06255301 | Completed

• 2 other identifiers: 19CH2182020-A00139-30
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Eye Diseases

Keywords

biomarkers; limbic stem cell deficiency; dry syndrome; EYEPRIM

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Control group

150 patients with eye diseases other than dry eye syndrome or limbal stem cell deficiency will be included.

Diagnostic Test: EYEPRIM

dry eye syndrome

100 patients with dry eye syndrome will be included.

Diagnostic Test: EYEPRIM

limbal stem cell deficiency

50 patients with limbal stem cell deficiency will be included.

Diagnostic Test: EYEPRIM

Interventions

EYEPRIM DIAGNOSTIC_TEST

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.

Control group; dry eye syndrome; limbal stem cell deficiency

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* 50 patients with limbal stem cell deficiency * 100 patients with dry eye syndrome * 150 patients with eye diseases other than dry eye syndrome or limbal stem cell deficiency

You may qualify if:

• 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

You may not qualify if:

• Major blepharospasm making examination impossible
• Pregnant women
• Breastfeeding women
• Protected Persons

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• Laboratoire Biologie, Ingénierie et Imagerie de la Greffe de Cornée (BiiGC): collaborator

Study Sites (1)

CHU Saint-Etienne

Saint-Etienne, France

Location

MeSH Terms

Conditions

Eye Diseases

Study Officials

• Gilles THURET, MD PhD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: February 13, 2024
• Study Start: January 9, 2024
• Primary Completion: March 21, 2024
• Study Completion: March 21, 2024
• Last Updated: April 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)