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

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ClinicalTrials.gov Identifier: NCT02713399
Recruitment Status : Unknown
Verified December 2017 by Gerhard Garhofer, Medical University of Vienna.
Recruitment status was:  Recruiting
First Posted : March 18, 2016
Last Update Posted : December 29, 2017
Sponsor:
Information provided by (Responsible Party):
Gerhard Garhofer, Medical University of Vienna

Brief 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.

Condition or disease Intervention/treatment
Contact Lens Tear Film Thickness Device: Optical Coherence Tomography

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: High-resolution Imaging of Tear Film Thickness in Contact Lenses Wearers With Optical Coherence Tomography (OCT). A Pilot Study
Study Start Date : March 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear Tears

Group/Cohort Intervention/treatment
Soft Contact Lenses
healthy subjects wearing soft contact lenses
Device: Optical Coherence Tomography
Rigid Contact Lenses
healthy subjects wearing rigid contact lenses
Device: Optical Coherence Tomography



Primary Outcome Measures :
  1. Pre lens and post lens tear film thickness [ Time Frame: 2 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
15 soft contact lens wearers 15 rigid contact lens wearers
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02713399


Contacts
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Contact: Gerhard Garhöfer, Assoc. Prof. PD Dr. +43 1 4040029880 gerhard.garhoefer@meduniwien.ac.at

Locations
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Austria
Department of Clinical Pharmacology, Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Gerhard Garhöfer, Assoc. Prof. PD Dr.    +43 (1) 40400 ext 29810    gerhard.garhoefer@meduniwien.ac.at   
Sub-Investigator: Piotr A Wozniak, MD         
Sub-Investigator: Klemens Fondi, MD         
Sub-Investigator: Ahmed Bata, MD         
Sub-Investigator: Doreen Schmidl, MD,PhD         
Sub-Investigator: Rene M Werkmeister, PhD         
Sub-Investigator: Gerhard Garhoefer, MD         
Sub-Investigator: Leopold Schmetterer, PhD         
Sponsors and Collaborators
Medical University of Vienna

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Responsible Party: Gerhard Garhofer, Assoc. Prof. PD Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02713399     History of Changes
Other Study ID Numbers: OPHT-150116
First Posted: March 18, 2016    Key Record Dates
Last Update Posted: December 29, 2017
Last Verified: December 2017