Investigating Tear Film Thickness for Dry Eye Syndrome
Assessment of TFT by OCT in Healthy Subjects and Subjects With DES
Recruiting
Observational Study
Dry Eye Syndromes
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
340 (estimated)
Sponsor
Medical University of Vienna · Other
Who this trial is looking for
This trial is looking for healthy individuals and patients with dry eye syndrome. Participants will help researchers understand how tear film thickness relates to the severity of dry eye symptoms.
Are You a Good Fit for This Trial?
Must not be takingCorticosteroids
Rules you outStevens-Johnson syndrome
You may be able to join if
I am over 18 years old.
I have dry eyes for three months or longer.
I use artificial tear eyedrops or gel.
I have been diagnosed with dry eye syndrome.
I have normal ophthalmic findings.
You may not be able to join if
I have participated in another clinical trial in the past 3 weeks.
I have symptoms of a relevant illness in the past 3 weeks.
I wear contact lenses.
I have taken dietary supplements in the past 3 months.
I have a history of glaucoma.
I have had ocular surgery in the past 3 months.
I am pregnant, planning to become pregnant, or am lactating.
I have Sjögren's syndrome.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Dry eye syndrome (DES) is a highly prevalent ocular condition with potential severe consequences for affected patients. DES can be either caused by decreased tear production or increased tear evaporation, both leading to an instable tear film. Despite many efforts, generally accepted methodologies to diagnose, assess the severity and monitor DES are still lacking. Moreover, widely used clinical me…
Dry eye syndrome (DES) is a highly prevalent ocular condition with potential severe consequences for affected patients. DES can be either caused by decreased tear production or increased tear evaporation, both leading to an instable tear film. Despite many efforts, generally accepted methodologies to diagnose, assess the severity and monitor DES are still lacking. Moreover, widely used clinical methods such as tear break up time (BUT), fluorescein staining of the cornea or Schirmer test only poorly reflect patients´ complains.
One of the main problems in the diagnosis and treatment of DES is that the most critical component - the tear film itself - is difficult to characterize. The development of new ultra-high resolution optical coherence tomography systems allows now for the direct visualization of the human tear film and for the non-invasive in-vivo measurement of tear film thickness (TFT). The investigators could recently show that this system provides excellent reproducibility and is able to assess even subtle changes in TFT induced by therapeutic interventions. However, to which extent tear film thickness is associated with other standard clinical measures of DES is currently unknown. In the present study, the investigators set out to test the hypothesis that ocular TFT is a new and good surrogate parameter for the assessment of the severity of DES.
Consequently, the aim of the study presented in this protocol is to investigate whether and if so, to what extent clinical signs of DES and reported symptoms are reflected in ocular TFT. For this purpose, a cross sectional study in healthy subjects and patients with DES will be performed. This should allow the investigators to more specifically characterize the role of the tear film in DES and to assess whether measurement of TFT with OCT can be a promising surrogate parameter for the diagnosis and the follow up of DES.
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Eligibility 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 …
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
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