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

NCT ID: NCT02713399

Last Updated: 2022-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-16

Study Completion Date

2023-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Contact Lens Tear Film Thickness

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Soft Contact Lenses

healthy subjects wearing soft contact lenses

Optical Coherence Tomography

Intervention Type DEVICE

Rigid Contact Lenses

healthy subjects wearing rigid contact lenses

Optical Coherence Tomography

Intervention Type DEVICE

Interventions

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Optical Coherence Tomography

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Gerhard Garhofer

Assoc. Prof. PD Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Clinical Pharmacology, Medical University of Vienna

Vienna, , Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Gerhard Garhöfer, Assoc. Prof. PD Dr.

Role: CONTACT

+43 1 4040029880

Facility Contacts

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Gerhard Garhöfer, Assoc. Prof. PD Dr.

Role: primary

+43 (1) 40400 ext. 29810

Other Identifiers

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OPHT-150116

Identifier Type: -

Identifier Source: org_study_id

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