Assessment of TFT by OCT in Healthy Subjects and Subjects With DES (NCT02585414) | Clinical Trial Compass
RecruitingNot Applicable
Assessment of TFT by OCT in Healthy Subjects and Subjects With DES
Austria340 participantsStarted 2017-08-31
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is measuring tear film thickness using a technology called OCT — can you explain what that procedure actually involves and whether it's comfortable or involves any eye contact or drops?
2Since this study is listed as 'Phase NA,' it seems like it's more of an observational or measurement study rather than a treatment trial — does that mean there's no experimental drug or intervention involved, and what would I actually gain from participating?
3The trial includes both healthy subjects and people with dry eye syndrome — given my specific situation, would I be enrolled as a dry eye patient, and how might that affect what the study asks of me?
4If this study is mainly measuring my tear film rather than treating my dry eye, should I also be discussing active treatment options for my dry eye syndrome at the same time, so my symptoms don't go unaddressed while I'm participating?
5Are there any risks to having my tear film measured repeatedly with OCT, and how many visits would typically be required for a study like this?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Tear Film Thickness (TFT) as measured with Optical Coherence Tomography (OCT)