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Recruiting NCT06841471

Role of Corneal Nerves in Dry Eye Disease

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Dry Eye Disease (DED), Dry Eye, Dry Eye Sensation, Corneal Nerve. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • Differences of corneal nerve function and morphology in relation with DED signs [Time frame: within one week]
Secondary outcome measures (1)
  • Differences of corneal nerve function and morphology in relation with DED symptoms [Time frame: within one week]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Switzerland · 1 center
  • Institute of Optometrym FHNW — Olten

Publications

  • 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. PMID 28736339

Identifiers

NCT: NCT06841471 · 2024-01949 · 2024-01949

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗