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

Launched by MEDICAL UNIVERSITY OF VIENNA · Oct 22, 2015

Keywords

ClinConnect Summary

This clinical trial is investigating a new way to assess dry eye syndrome (DES) by measuring the thickness of the tear film in the eye using a special imaging technology called optical coherence tomography (OCT). DES is a common condition that can cause discomfort and impact daily life, but current methods to diagnose and monitor it may not fully reflect patients' experiences. The researchers hope that by studying both healthy individuals and those with DES, they can determine if the thickness of the tear film can serve as a reliable indicator of the severity of dry eye symptoms.

To participate in this study, you need to be at least 18 years old. If you are a healthy volunteer, you should have normal eye health. If you have dry eye syndrome, you must have been diagnosed by a doctor and experienced symptoms like dryness, itching, or a sandy feeling in your eyes for at least three months. Participants will undergo non-invasive tests to measure tear film thickness and may be asked about their symptoms and medical history. It's also important to note that certain conditions or recent treatments may exclude you from participating. This study aims to better understand dry eye syndrome and improve how it is diagnosed and treated in the future.

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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 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