Role of Corneal Nerves in Dry Eye Disease

March 10, 2025 updated by: Daniela Nosch

Association Between Corneal Sensitivity, Nerve Morphology, Tear Film Homeostasis and Dry Eye Symptoms

This study aims to determine whether corneal nerve function and morphology are affected by tear film instability and ocular surface homeostasis loss. Additionally, it seeks to investigate whether these factors vary based on the severity of dry eye symptoms.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Switzerland
      • Olten, Switzerland, 4600
        • Recruiting
        • Institute of Optometrym FHNW
        • Contact:
        • Principal Investigator:
          • Emanuele Käser, BSc MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

healthy adults as well as adult with dry eye disease

Description

Inclusion Criteria:

  • Group with DED: Diagnosis of DED based on the TFOS DEWS II report
  • Group without DED: No diagnosis of DED

Exclusion Criteria:

  • Exclusion criteria:
  • Systemic disease that may affect ocular health and innervation
  • injury or history of operations on the anterior or posterior segment of the eye, which can affect the corneal structure and physiology
  • regular application of systemic or ocular medication known to affect the tear film except from DED medications
  • eye drops or makeup on the day of measurement.

Remarks:

Contact lens wearers are asked not to wear contact lenses for 1 week before the first appointment.

Participant with DED medications will be asked to use only conservative-free eye drops on the days of examination

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Control
healthy adults
DED group
Adults with Dry Eye following the TFOS DEWS II Diagnosis consensus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences of corneal nerve function and morphology in relation with DED signs
Time Frame: within one week
Correlation coefficient between corneal sensitivity and corneal nerve morphology, and variables related to tear film stability and corneal surface homeostasis.
within one week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences of corneal nerve function and morphology in relation with DED symptoms
Time Frame: within one week
Correlation coefficient between corneal sensitivity, corneal nerve morphology, and the severity of dry eye symptoms.
within one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daniela Nosch

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2025

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

February 17, 2025

First Submitted That Met QC Criteria

February 21, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 10, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-01949 (Registry Identifier: REGISTRY: Swissethics)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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