Dry Eye Syndrome
Conditions
Keywords
break up time, tear film thickness, tear film osmolarity, objective scattering index, impression cytology, tear cytokines/chemokines, visual acuity, fluorescein staining
Brief summary
Dry eye syndrome (DES) is a highly prevalent ocular condition inducing an inflammatory response of the ocular surface. Common symptoms include ocular discomfort, visual impairment and instability of the tear film with potential damage to the ocular surface. The rationale of the present study is to compare signs as assessed with new methods such as measurement of tear film thickness, tear film osmolarity and scattering of the tear film with well established methods for assessment of the severity of DES (Break up time, staining of the cornea with fluorescein). Additionally, impression cytology and determination of tear cytokines/chemokines will be performed to obtain information about inflammatory processes on the ocular surface.
Interventions
OTHEROcular scattering of the tear film
OTHEROptical Coherence Tomography (OCT)
Tear film thickness as measured with OCT
OTHERMeasurement of tear film osmolarity
Sponsors
Medical University of Vienna
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men and women aged over 18 years * History of dry eye syndrome for at least 3 months * At least 2 symptoms of dry eye syndrome (foreign body sensation, burning, photophobia, blurred vision, pain, itching) and/or tear break up time \< 10 seconds * 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 * Presence or history of a severe medical condition that will interfere with the study aim as judged by the clinical investigator * Wearing of contact lenses * Intake of dietary supplements in the 3 months preceding the study * Glaucoma * Treatment with corticosteroids in the 4 weeks preceding the study * Topical treatment with any ophthalmic drug in the 4 weeks preceding the study except topical lubricants * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Break up time | once on the study day | break up time of the tear film measured in seconds |
| Tear film thickness as measured with optical coherence tomography (OCT) | once on the study day | tear film thickness measured in micrometers |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OSI (Objective Scattering Index) | once on the study day | The objective scattering index will be measured using the OQAS system (Visiometrics, Spain) |
| Staining of the cornea with fluorescein | once on the study day | The cornea will be divided into 5 regions (central, inferior, nasal, temporal, inferior) and each region will be graded from 0-4 in 0.5 steps as described in the Collaborative Longitudinal Evaluation of Keratoconus (CLEK) study. |
| Visual Acuity | once on the study day | Total number of letters read using ETDRS Charts |
| Tear cytokines/chemokines | once on the study day | Samples of 40 µl tears will be taken with a glass capillary and stored in vials. The concentrations of several cytokines and chemokines will be evaluated. |
| Subjective symptoms of dry eye syndrome | once on the study day | a questionaire will be used |
| Impression cytology | once on the study day | After topical anesthesia of the eye, filter material is placed on the conjunctiva to obtain cytological samples, which will be prepared and evaluated. |
| Tear film osmolarity | once on the study day | Tear film osmolarity measured in mosmol/l |
Countries
Austria
Outcome results
None listed