| Registry | NCT02713399 |
|---|---|
| Status | Unknown |
| Study type | Observational |
| Enrollment | 30 (Estimated) |
| Sponsor | Medical University of Vienna (Other) |
| Conditions | Contact Lens, Tear Film Thickness |
| Interventions | Optical Coherence Tomography (Device) |
| Dates | start 2016-03-16, primary completion 2023-09-01 (estimated), completion 2023-11-01 (estimated), first posted 2016-03-18, last updated 2022-04-07 |
| Locations | 1 site in Austria |
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A refractive error is the most common reason for reduced visual acuity. Myopia, hyperopia, astigmatism and presbyopia belong to the four basic refractive errors and, unfortunately, cannot be prevented. There are different tools to correct them, like spectacles, contact lenses, and refractive surgery. Many different contact lenses are available, the two large groups create rigid contact lenses and soft contact lenses. It is a common knowledge that the presence of a contact lens in the eye divides the tear film into the prelens and postlens tear film layers. In the present study we want to investigate the variability and reproducibility of prelens and postlens tear film thickness measurements.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Soft Contact Lenses | Device: Optical Coherence Tomography | healthy subjects wearing soft contact lenses | |
| Rigid Contact Lenses | Device: Optical Coherence Tomography | healthy subjects wearing rigid contact lenses |
Sex: All, ages: 18 Years to any, accepts healthy volunteers
Inclusion criteria * Men and women aged over 18 years * Soft or rigid contact lenses wearers * Schirmer Test ≥ 10 mm/5 min * Tear Breakup Time (TBUT) ≥10 seconds Exclusion Criteria: * Participation in a clinical trial in the previous 3 weeks * Presence of any abnormalities preventing reliable measurements as judged by the investigator * Pregnancy, planned pregnancy or lactating
| Facility | City | Country | Status |
|---|---|---|---|
| Department of Clinical Pharmacology, Medical University of Vienna | Vienna | Austria | Recruiting |