Contact LensNCT02713399
High-resolution Imaging of Tear Film Thickness in Contact Lenses Wearers With Optical Coherence Tomography (OCT). A Pilot Study
An observational study of Contact Lens and Tear Film Thickness, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Contact Lens, Tear Film Thickness
- What is being tested?
- Optical Coherence Tomography
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteAustria
- Study dates
- 16 Mar 2016to Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 15 soft contact lens wearers 15 rigid contact lens wearers
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, 1090
Gerhard Garhöfer, Assoc. Prof. PD Dr., +43 (1) 40400 ext. 29810, gerhard.garhoefer@meduniwien.ac.at
Piotr A Wozniak, MD
About this study
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.
- Conditions
- Contact Lens, Tear Film Thickness
- Being tested
- Optical Coherence Tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical Coherence TomographyDevice
| Study group | Role | What they receive |
|---|---|---|
| Soft Contact Lenses | healthy subjects wearing soft contact lenses Receives: Device: Optical Coherence Tomography | |
| Rigid Contact Lenses | healthy subjects wearing rigid contact lenses Receives: Device: Optical Coherence Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre lens and post lens tear film thickness
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2016 (estimated)
- Study start16 Mar 2016
- Primary completionSep 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contact LensStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerhard Garhofer, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02713399
- Sponsor's protocol ID
- OPHT-150116
- Status last verified
- Apr 2022
- First submitted
- 15 Mar 2016
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-resolution Imaging of Tear Film Thickness in Contact Lenses Wearers With Optical Coherence Tomography (OCT). A Pilot Study
- ClinicalTrials.gov ID
- NCT02713399
- Acronym / sponsor ID
- OPHT-150116
- Conditions
- Contact Lens, Tear Film Thickness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 16 Mar 2016 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 18 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Soft Contact Lenses | – | Device: Optical Coherence Tomographyhealthy subjects wearing soft contact lenses |
| Rigid Contact Lenses | – | Device: Optical Coherence Tomographyhealthy subjects wearing rigid contact lenses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 15 soft contact lens wearers 15 rigid contact lens wearers
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optical Coherence Tomography | Device | Rigid Contact Lenses, Soft Contact Lenses |
Primary outcome
Pre lens and post lens tear film thickness
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Contact Lens and Tear Film Thickness, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gerhard Garhöfer, Assoc. Prof. PD Dr. (+43 1 4040029880, gerhard.garhoefer@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre lens and post lens tear film thickness (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2022.