Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
ID02585414

Assessment of Tear Film Thickness by Optical Coherence Tomography in Healthy Subjects and Subjects With Dry Eye Disease

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

340

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating dry eye syndrome (DES), a common eye condition that can cause serious problems due to either reduced tear production or increased tear evaporation, resulting in an unstable tear film. Current clinical methods to diagnose and assess DES often do not match patients' symptoms well. This study aims to explore how measuring tear film thickness (TFT) with a new high-resolution imaging technology called optical coherence tomography (OCT) relates to other clinical signs and symptoms of DES, potentially offering a better way to diagnose and monitor this condition. The study involves a cross-sectional comparison between healthy adults without DES and adults diagnosed with DES. Using OCT, researchers will measure the thickness of the tear film in participants' eyes non-invasively. They will also assess other clinical measures of DES such as tear break-up time, corneal staining, Schirmer test results, tear osmolarity, and symptom questionnaires. This approach helps to understand how TFT correlates with standard assessments and symptoms in both healthy and affected individuals. Participants will be adults aged 18 years or older, including healthy volunteers and those with DES. They will undergo various eye examinations and complete questionnaires about their symptoms. The main measurement is tear film thickness using OCT, with other clinical tests performed at the same time. Researchers will analyze these data to see how well TFT reflects the severity of DES. The study is observational, with no treatments given, and participants' involvement includes a one-month evaluation period with clinical assessments and symptom reporting.

CONDITIONS

Brief 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 unless clinically irrelevant abnormalities, normal eye findings, and ametropia less than 6 diopters
  • For dry eye syndrome patients: diagnosed with DES, currently using artificial tear eyedrops or gel, and having dry eyes for three months or longer with symptoms such as itching, burning, or sandy feeling not related to allergy
  • Normal ophthalmic findings except for dry eye syndrome in DES patients
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 month

Participants undergo measurements including tear film thickness by optical coherence tomography and other eye assessments.

1 visit (in-person)

Long-term Monitoring

Duration - 1 month

Participants are observed to assess changes in eye condition over 1 month following the initial diagnostic evaluation.

1 follow-up visit (in-person)

Trial Site Locations

Total: 1 location

1

Department of Clinical Pharmacology, Medical University of Vienna, Austria

Vienna, Austria, 1090

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Research Team

G

Gerhard Garhofer, MD

D

Doreen Schmidl, MD, PhD

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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