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

April 6, 2022 updated by: Gerhard Garhofer, Medical University of Vienna
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Recruiting
        • Department of Clinical Pharmacology, Medical University of Vienna
        • Contact:
        • Sub-Investigator:
          • Piotr A Wozniak, MD
        • Sub-Investigator:
          • Doreen Schmidl, MD,PhD
        • Sub-Investigator:
          • Rene M Werkmeister, PhD
        • Sub-Investigator:
          • Gerhard Garhoefer, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

15 soft contact lens wearers 15 rigid contact lens wearers

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pre lens and post lens tear film thickness
Time Frame: 2 months
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 16, 2016

Primary Completion (ANTICIPATED)

September 1, 2023

Study Completion (ANTICIPATED)

November 1, 2023

Study Registration Dates

First Submitted

March 15, 2016

First Submitted That Met QC Criteria

March 15, 2016

First Posted (ESTIMATE)

March 18, 2016

Study Record Updates

Last Update Posted (ACTUAL)

April 7, 2022

Last Update Submitted That Met QC Criteria

April 6, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • OPHT-150116

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Contact Lens

Clinical Trials on Optical Coherence Tomography

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belarus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe