Assessing tear film thickness in healthy individuals and those with dry eye syndrome
Assessment of Tear Film Thickness by Optical Coherence Tomography in Healthy Subjects and Subjects With Dry Eye Disease
This study is testing a new way to measure tear film thickness in both healthy people and those with dry eye syndrome to see if it can help improve how we diagnose and treat the condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 340 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of Vienna Academic / other |
| Locations | 1 site (Vienna) |
| Trial ID | NCT02585414 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate tear film thickness (TFT) using advanced optical coherence tomography (OCT) in both healthy subjects and patients diagnosed with dry eye syndrome (DES). The study seeks to address the challenges in diagnosing and monitoring DES, which is often inadequately assessed by traditional methods. By utilizing ultra-high resolution OCT, the researchers hope to provide a more accurate characterization of the tear film, potentially leading to improved diagnostic and treatment strategies for DES.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years with either a diagnosis of dry eye syndrome or healthy individuals with normal ophthalmic findings.
Not a fit: Patients with recent participation in other clinical trials or those with clinically relevant illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the diagnosis and management of dry eye syndrome, leading to better patient outcomes.
How similar studies have performed: While the use of OCT for assessing tear film thickness is a novel approach, similar studies have shown promise in improving diagnostic accuracy for ocular conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Inclusion criteria for healthy volunteers * Men and women aged over 18 years * Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant * Normal ophthalmic findings, ametropia \< 6 Dpt. Inclusion criteria for patients with DES: * Men and women aged over 18 years * DES patients will be included based on three questions: * (1) "Have you ever been diagnosed (by a clinician) as having dry eye syndrome?" * (2) "Do you currently use artificial tear eyedrops or gel?" * (3) "For the past three months or longer, have you had dry eyes? (This is described as a foreign body sensation with itching and burning, sandy feeling, not related to allergy)." * Normal ophthalmic findings except dry eye syndrome Exclusion Criteria: * Participation in a clinical trial in the 3 weeks preceding the study * Symptoms of a clinically relevant illness in the 3 weeks before the first study day * Wearing of contact lenses * Intake of dietary supplements in the 3 months preceding the study * History of glaucoma * Treatment with corticosteroids in the 4 weeks preceding the study to topical treatment with any ophthalmic drug in the 4 weeks preceding the study (topical lubricants for patients with DES are allowed) * Ocular infection or clinically significant inflammation * Ocular surgery in the 3 months preceding the study * Sjögren's syndrome * Stevens-Johnson syndrome * Pregnancy, planned pregnancy or lactating
Where this trial is running
Vienna
- Department of Clinical Pharmacology, Medical University of Vienna, Austria — Vienna, Austria (Recruiting)
Study contacts
- Study coordinator: Gerhard Garhofer, MD
- Email: gerhard.garhoefer@meduniwien.ac.at
- Phone: +43 1 40400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.