Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
NCT02585414

Assessment of TFT by OCT in Healthy Subjects and Subjects With DES

Led by Medical University of Vienna · Updated on 2025-05-23

340

Participants Needed

1

Research Sites

482 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Assessment of TFT by OCT in Healthy Subjects and Subjects With DES

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Men and women aged over 18 years
  • For healthy volunteers: normal medical history and normal eye exam with ametropia less than 6 diopters
  • For dry eye syndrome patients: diagnosis by a clinician, current use of artificial tear drops or gel, and dry eye symptoms for three months or longer
  • Normal eye exam except for dry eye syndrome in DES patients
Not Eligible

You will not qualify if you...

  • Participation in another clinical trial within 3 weeks before this study
  • Symptoms of a significant illness within 3 weeks before the first study day
  • Wearing contact lenses
  • Use of dietary supplements within 3 months before the study
  • History of glaucoma
  • Treatment with corticosteroids or any ophthalmic drug (except topical lubricants for DES patients) within 4 weeks before the study
  • Eye infection or significant eye inflammation
  • Eye surgery within 3 months before the study
  • Having Sj�f6gren's syndrome or Stevens-Johnson syndrome
  • Pregnancy, planned pregnancy, or breastfeeding

AI-Screening

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Trial Site Locations

Total: 1 location

1

Department of Clinical Pharmacology, Medical University of Vienna, Austria

Vienna, Austria, 1090

Actively Recruiting

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Research Team

G

Gerhard Garhofer, MD

CONTACT

D

Doreen Schmidl, MD, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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