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

• Sponsor: Medical University of Vienna (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT02713399
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Anticipated Duration (Months): 91.5
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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	Phase
Contact Lens; Tear Film Thickness	Device: Optical Coherence Tomography

Study Design

• Study Type: Observational
• Anticipated 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
• Actual Study Start Date: Mar 16, 2016
• Anticipated Primary Completion Date: Sep 1, 2023
• Anticipated Study Completion Date: Nov 1, 2023

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Pre lens and post lens tear film thickness [2 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Clinical Pharmacology, Medical University of Vienna	Vienna		Austria	1090

Sponsors and Collaborators

• Medical University of Vienna

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gerhard Garhofer, Assoc. Prof. PD Dr., Medical University of Vienna
• ClinicalTrials.gov Identifier: NCT02713399
• Other Study ID Numbers: OPHT-150116
• First Posted: Mar 18, 2016
• Last Update Posted: Apr 7, 2022
• Last Verified: Apr 1, 2022

Study Results

No Results Posted as of Apr 7, 2022