NCT02713399

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2016

Completed
1 day until next milestone

Study Start

First participant enrolled

March 16, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 18, 2016

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

April 7, 2022

Status Verified

April 1, 2022

Enrollment Period

7.5 years

First QC Date

March 15, 2016

Last Update Submit

April 6, 2022

Conditions

Contact LensTear Film Thickness

Outcome Measures

Primary Outcomes (1)

  • Pre lens and post lens tear film thickness

    2 months

Study Arms (2)

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

Interventions

Optical Coherence TomographyDEVICE
Rigid Contact LensesSoft Contact Lenses

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

15 soft contact lens wearers 15 rigid contact lens wearers

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Interventions

Tomography, Optical Coherence

Intervention Hierarchy (Ancestors)

Tomography, OpticalOptical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomographyInvestigative Techniques

Central Study Contacts

Gerhard Garhöfer, Assoc. Prof. PD Dr.

CONTACT

+43 1 4040029880gerhard.garhoefer@meduniwien.ac.at

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. PD Dr.

Study Record Dates

First Submitted

March 15, 2016

First Posted

March 18, 2016

Study Start

March 16, 2016

Primary Completion

September 1, 2023

Study Completion

November 1, 2023

Last Updated

April 7, 2022

Record last verified: 2022-04

Locations

AU(1)