Corneal AbrasionsNCT01753583
High-resolution Imaging of Corneal Lesions With Optical Coherence Tomography (OCT) - A Pilot Study
A study testing Optical Coherence Tomography (OCT) and Slit lamp biomicroscopy in people with Corneal Abrasions and Corneal Infiltrates, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Corneal lesions such as corneal abrasions and corneal infiltrates are common in clinical practice. The current study seeks to investigate whether high-resolution OCT is suitable for imaging of these corneal lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Corneal Abrasions, Corneal Infiltrates
- What is being tested?
- Optical Coherence Tomography (OCT) and Slit lamp biomicroscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteAustria
- Study dates
- 23 Jul 2013to 1 Mar 2016
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged over 18 years
- Newly diagnosed corneal abrasion or corneal infiltrate
Who cannot join
- Recurrent corneal erosion
- Participation in a clinical trial in the previous 3 weeks
- Presence of any abnormalities preventing reliable measurements as judged by the investigator
- Any contraindication for topical application of Novain 0.4% eye drops for topical anesthesia or of Minims-Fluorescein Sodium eye drops for fluorescein staining
- Pregnancy, planned pregnancy or lactating
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, 1090
About this study
Corneal lesions such as corneal abrasions and corneal infiltrates are common in clinical practice. The current study seeks to investigate whether high-resolution OCT is suitable for imaging of these corneal lesions. The present study has the character of a pilot study and the results are intended to be used to develop a standardized protocol for imaging and analysis of these corneal lesions. Based on this protocol, further studies investigating the pathophysiology of corneal lesions or evaluating therapeutic success can be planned.
- Conditions
- Corneal Abrasions, Corneal Infiltrates
- Being tested
- Optical Coherence Tomography (OCT), Slit lamp biomicroscopy
- Keywords
- optical coherence tomography, corneal abrasion, corneal infiltrate
- Medical subject headings
- Corneal Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical Coherence Tomography (OCT)Device
High-resolution OCT imaging of the cornea
Slit lamp biomicroscopyOther
Slit lamp biomicroscopy with fluorescein staining and slit lamp photograph
| Study group | Role | What they receive |
|---|---|---|
| 10 patients with corneal abrasions | Experimental | Not described Receives: Device: Optical Coherence Tomography (OCT); Other: Slit lamp biomicroscopy |
| 10 patients with corneal infiltrates | Experimental | Not described Receives: Device: Optical Coherence Tomography (OCT); Other: Slit lamp biomicroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Imaging of corneal abrasions and infiltrates
The aim of this pilot study is to investigate whether imaging of these corneal alterations is possible.
Measured: 1 day
Secondary outcomes (2)
Size and depth of corneal lesions as assessed with high-resolution OCT
The volume and size of corneal lesions or infiltrates will be assessed using a specific software.
Measured: 1 day
Slit lamp biomicroscopy with fluorescein staining
The volume and size of corneal lesions or infiltrates will be assessed.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2012 (estimated)
- Study start23 Jul 2013
- Primary completion1 Mar 2016
- Study completion1 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal AbrasionsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
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
- NCT01753583
- Sponsor's protocol ID
- OPHT-041112
- Status last verified
- Feb 2020
- First submitted
- 7 Dec 2012
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-resolution Imaging of Corneal Lesions With Optical Coherence Tomography (OCT) - A Pilot Study
- ClinicalTrials.gov ID
- NCT01753583
- Acronym / sponsor ID
- OPHT-041112
- Conditions
- Corneal Abrasions, Corneal Infiltrates
- Keywords
- optical coherence tomography, corneal abrasion, corneal infiltrate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 23 Jul 2013 (actual)
- Primary completion
- 1 Mar 2016 (actual)
- Study completion
- 1 Mar 2016 (actual)
- First posted
- 20 Dec 2012 (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.
Corneal lesions such as corneal abrasions and corneal infiltrates are common in clinical practice. The current study seeks to investigate whether high-resolution OCT is suitable for imaging of these corneal lesions. The present study has the character of a pilot study and the results are intended to be used to develop a standardized protocol for imaging and analysis of these corneal lesions. Based on this protocol, further studies investigating the pathophysiology of corneal lesions or evaluating therapeutic success can be planned.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10 patients with corneal abrasions | Experimental | Device: Optical Coherence Tomography (OCT), Other: Slit lamp biomicroscopy |
| 10 patients with corneal infiltrates | Experimental | Device: Optical Coherence Tomography (OCT), Other: Slit lamp biomicroscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men and women aged over 18 years
- Newly diagnosed corneal abrasion or corneal infiltrate
Key exclusion criteria (5 listed)
- Recurrent corneal erosion
- Participation in a clinical trial in the previous 3 weeks
- Presence of any abnormalities preventing reliable measurements as judged by the investigator
- Any contraindication for topical application of Novain 0.4% eye drops for topical anesthesia or of Minims-Fluorescein Sodium eye drops for fluorescein staining
- 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 (OCT)High-resolution OCT imaging of the cornea | Device | 10 patients with corneal abrasions, 10 patients with corneal infiltrates |
| Slit lamp biomicroscopySlit lamp biomicroscopy with fluorescein staining and slit lamp photograph | Other | 10 patients with corneal abrasions, 10 patients with corneal infiltrates |
Primary outcome
Imaging of corneal abrasions and infiltrates
Time frame: 1 day
The aim of this pilot study is to investigate whether imaging of these corneal alterations is possible.
2 secondary outcomes
Size and depth of corneal lesions as assessed with high-resolution OCT
Time frame: 1 day
Slit lamp biomicroscopy with fluorescein staining
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optical Coherence Tomography (OCT) and Slit lamp biomicroscopy in people with Corneal Abrasions and Corneal Infiltrates, 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 2 inclusion and 5 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: finished, as of the sponsor's last update on 20 Feb 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Imaging of corneal abrasions and infiltrates (time frame: 1 day). 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 20 Feb 2020.