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

NCT ID: NCT06255301

Last Updated: 2024-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-09

Study Completion Date

2024-03-21

Brief Summary

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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

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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.

Conditions

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Eye Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Control group

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

EYEPRIM

Intervention Type 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.

dry eye syndrome

100 patients with dry eye syndrome will be included.

EYEPRIM

Intervention Type 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.

limbal stem cell deficiency

50 patients with limbal stem cell deficiency will be included.

EYEPRIM

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Laboratoire Biologie, Ingénierie et Imagerie de la Greffe de Cornée (BiiGC)

UNKNOWN

Sponsor Role collaborator

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gilles THURET, MD PhD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

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CHU Saint-Etienne

Saint-Etienne, , France

Site Status

Countries

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France

Other Identifiers

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2020-A00139-30

Identifier Type: OTHER

Identifier Source: secondary_id

19CH218

Identifier Type: -

Identifier Source: org_study_id

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