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High-resolution Imaging of Tear Film Thickness in Contact Lenses Wearers With Optical Coherence Tomography (OCT). A Pilot Study

NCT02713399 — Unknown, 30 participants, Medical University of Vienna

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RegistryNCT02713399
StatusUnknown
Study typeObservational
Enrollment30 (Estimated)
SponsorMedical University of Vienna (Other)
ConditionsContact Lens, Tear Film Thickness
InterventionsOptical Coherence Tomography (Device)
Datesstart 2016-03-16, primary completion 2023-09-01 (estimated), completion 2023-11-01 (estimated), first posted 2016-03-18, last updated 2022-04-07
Locations1 site in Austria

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-Summary

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.

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+Arms and interventions

ArmTypeInterventionsDescription
Soft Contact LensesDevice: Optical Coherence Tomographyhealthy subjects wearing soft contact lenses
Rigid Contact LensesDevice: Optical Coherence Tomographyhealthy subjects wearing rigid contact lenses
  • Optical Coherence Tomography (Device)

+Outcome measures

Primary outcomes

  • Pre lens and post lens tear film thickness [2 months]

+Eligibility

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

+Locations (1)

FacilityCityCountryStatus
Department of Clinical Pharmacology, Medical University of ViennaViennaAustriaRecruiting

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