Role of Corneal Nerves in Dry Eye Disease
Association Between Corneal Sensitivity, Nerve Morphology, Tear Film Homeostasis and Dry Eye Symptoms
1 other identifier
observational
140
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2025
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2025
CompletedStudy Start
First participant enrolled
February 20, 2025
CompletedFirst Posted
Study publicly available on registry
February 24, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedMarch 11, 2025
March 1, 2025
9 months
February 17, 2025
March 10, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Differences of corneal nerve function and morphology in relation with DED signs
Correlation coefficient between corneal sensitivity and corneal nerve morphology, and variables related to tear film stability and corneal surface homeostasis.
within one week
Secondary Outcomes (1)
Differences of corneal nerve function and morphology in relation with DED symptoms
within one week
Study Arms (2)
Control
healthy adults
DED group
Adults with Dry Eye following the TFOS DEWS II Diagnosis consensus
Eligibility Criteria
healthy adults as well as adult with dry eye disease
You may qualify if:
- Group with DED: Diagnosis of DED based on the TFOS DEWS II report
- Group without DED: No diagnosis of DED
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Daniela Noschlead
Study Sites (1)
Institute of Optometrym FHNW
Olten, 4600, Switzerland
Related Publications (1)
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: 28736339BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Week
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Lecturer
Study Record Dates
First Submitted
February 17, 2025
First Posted
February 24, 2025
Study Start
February 20, 2025
Primary Completion
December 1, 2025
Study Completion
December 1, 2025
Last Updated
March 11, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share