Role of Corneal Nerves in Dry Eye Disease

NCT ID: NCT06841471

Last Updated: 2025-03-11

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

RECRUITING

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-20

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Dry Eye Disease (DED) Dry Eye Dry Eye Sensation Corneal Nerve

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Control

healthy adults

No interventions assigned to this group

DED group

Adults with Dry Eye following the TFOS DEWS II Diagnosis consensus

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Daniela Nosch

OTHER

Sponsor Role lead

Responsible Party

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Daniela Nosch

Lecturer

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Institute of Optometrym FHNW

Olten, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Daniela S Nosch, BSc MSc PhD

Role: CONTACT

41629572603

Emanuele Käser, BSc MSc

Role: CONTACT

41629572302

Facility Contacts

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Daniela S Nosch, BSc MSc PhD

Role: primary

41629572603

References

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Belmonte C, Nichols JJ, Cox SM, Brock JA, Begley CG, Bereiter DA, Dartt DA, Galor A, Hamrah P, Ivanusic JJ, Jacobs DS, McNamara NA, Rosenblatt MI, Stapleton F, Wolffsohn JS. TFOS DEWS II pain and sensation report. Ocul Surf. 2017 Jul;15(3):404-437. doi: 10.1016/j.jtos.2017.05.002. Epub 2017 Jul 20.

Reference Type BACKGROUND
PMID: 28736339 (View on PubMed)

Other Identifiers

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2024-01949

Identifier Type: REGISTRY

Identifier Source: secondary_id

2024-01949

Identifier Type: -

Identifier Source: org_study_id

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