CorneaNCT02614625
Spectral-domain Optical Coherence Tomography of the Eye
An observational study of Cornea and Retina, run by Augenabteilung Allgemeines Krankenhaus Linz at 1 site in Austria.
Trial summary
An increasing number of clinical studies on SD-OCT of ocular pathologies and potential new clinical applications has recently been published in the peer-reviewed literature. However, the successful use of SD-OCT in routine clinical use depends upon the diagnostic sensitivity, biometric accuracy and reliability of the… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cornea, Retina, Refractive Surgery
- How many people
- 100 participants
- Where
- 1 siteAustria
- Study dates
- Dec 2014to Dec 2015
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 200 eyes of 100 patients will be included.
Who may be able to join
- Age 21 and older
- Normal eyes or
- Eyes with corneal disease:
- Subjects that have any of the following conditions
- Corneal dystrophy or degeneration
- Corneal scarring
Show all 25Show fewer
- Corneal ulcer
- Corneal injury
- Keratoconus
- Patients who had undergone corneal surgery
- Patients with other corneal disease or - Eyes with retinal disease:
- Subjects that have any of the following conditions:
- Diabetic macular edema
- Cystoid macular edema
- Age related macular degeneration
- Retinal vascular disorders (e.g. retinal artery occlusion)
- Epiretinal membrane
- Choroidal nevus
- Macular hole
- Patients who had undergone retinal surgery
- Patients with other retinal disease or
- Eyes with glaucoma
- Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant.
- AND
- Written informed consent prior to recruitment
Who cannot join
- Any of the following will exclude a subject from the study:
- Patients who are not able to cooperate or with insufficient ability to fixate (tremor, nystagmus)
- Pregnancy (pregnancy test will be taken in women of reproductive age before enrolment into the trial)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Comparative, Observational Study on Spectral-domain Optical Coherence Tomography of the Eye
An increasing number of clinical studies on SD-OCT of ocular pathologies and potential new clinical applications has recently been published in the peer-reviewed literature. However, the successful use of SD-OCT in routine clinical use depends upon the diagnostic sensitivity, biometric accuracy and reliability of the SD-OCT machines. This prospective, comparative, observational study aims to evaluate the imaging quality and diagnostic performance of two commercially available SD-OCT machines for both the anterior and posterior segment of the eye.
- Conditions
- Cornea, Retina, Refractive Surgery, Macular Edema, Diabetes, Diabetic Macular Edema
- Medical subject headings
- Corneal Diseases, Macular Edema, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Normal subjects | Patient with healthy, normal eyes | |
| Eyes with corneal disease | Subjects that have any of the following conditions * Corneal dystrophy or degeneration * Corneal scarring * Corneal ulcer * Corneal injury * Keratoconus * Patients who had undergone corneal surgery * Patients with other corneal disease | |
| Eyes with retinal disease | Subjects that have any of the following conditions: * Diabetic macular edema * Cystoid macular edema * Age related macular degeneration * Retinal vascular disorders (e.g. retinal artery occlusion) * Epiretinal membrane * Choroidal nevus * Macular hole * Patients who had undergone retinal surgery * Patients with other retinal disease | |
| Eyes with glaucoma | Eyes diagnosed with glaucoma of any type and any stage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity as the proportion of anatomical structures that are detectable with the two instruments
Anatomical structures include e.g. sublayers of the cornea, sublayers of the retina, retinal vessels etc.
Measured: 6 months
Secondary outcomes (2)
Corneal sublayer thickness (µm) and retinal sublayer thickness (µm) obtained with the two study instruments
Comparability is analyzed between various biometric values obtained with the two instruments and typical indices of comparability are produced (e.g. intraclass correlation coefficient)
Measured: 6 months
Corneal sublayer thickness and retinal sublayer thickness obtained with the two study instruments
Repeatability for various biometric values obtained with the two instruments is analyzed and typical indices of repeatability are produced (e.g. coefficient of variation)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2015 (estimated)
- Study startDec 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CorneaStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Augenabteilung Allgemeines Krankenhaus Linz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthias Bolz, MD, Principal investigator, AKh Linz, Augenabteilung
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02614625
- Sponsor's protocol ID
- OCTComparisonstudy1.1
- Status last verified
- Nov 2015
- First submitted
- 12 Oct 2015
- Last updated
- 25 Nov 2015
- Results posted
- No
Publications
Luft N, Ring MH, Dirisamer M, Mursch-Edlmayr AS, Kreutzer TC, Pretzl J, Bolz M, Priglinger SG. Corneal Epithelial Remodeling Induced by Small Incision Lenticule Extraction (SMILE). Invest Ophthalmol Vis Sci. 2016 Jul 1;57(9):OCT176-83. doi: 10.1167/iovs.15-18879.
PubMed 27409470
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Comparative, Observational Study on Spectral-domain Optical Coherence Tomography of the Eye
- ClinicalTrials.gov ID
- NCT02614625
- Acronym / sponsor ID
- OCTComparisonstudy1.1
- Conditions
- Cornea, Retina, Refractive Surgery, Macular Edema, Diabetes, Diabetic Macular Edema
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Augenabteilung Allgemeines Krankenhaus LinzUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 25 Nov 2015 (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.
An increasing number of clinical studies on SD-OCT of ocular pathologies and potential new clinical applications has recently been published in the peer-reviewed literature. However, the successful use of SD-OCT in routine clinical use depends upon the diagnostic sensitivity, biometric accuracy and reliability of the SD-OCT machines. This prospective, comparative, observational study aims to evaluate the imaging quality and diagnostic performance of two commercially available SD-OCT machines for both the anterior and posterior segment of the eye.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normal subjects | – | –Patient with healthy, normal eyes |
| Eyes with corneal disease | – | –Subjects that have any of the following conditions * Corneal dystrophy or degeneration * Corneal scarring * Corneal ulcer * Corneal injury * Keratoconus * Patients who had undergone corneal surgery * Patients with other corneal disease |
| Eyes with retinal disease | – | –Subjects that have any of the following conditions: * Diabetic macular edema * Cystoid macular edema * Age related macular degeneration * Retinal vascular disorders (e.g. retinal artery occlusion) * Epiretinal membrane * Choroidal nevus * Macular hole * Patients who had undergone retinal surgery * Patients with other retinal disease |
| Eyes with glaucoma | – | –Eyes diagnosed with glaucoma of any type and any stage |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 200 eyes of 100 patients will be included.
Key inclusion criteria (25 listed)
- Age 21 and older
- Normal eyes or
- Eyes with corneal disease:
- Subjects that have any of the following conditions
- Corneal dystrophy or degeneration
Key exclusion criteria (3 listed)
- Patients who are not able to cooperate or with insufficient ability to fixate (tremor, nystagmus)
- Pregnancy (pregnancy test will be taken in women of reproductive age before enrolment into the trial)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity as the proportion of anatomical structures that are detectable with the two instruments
Time frame: 6 months
Anatomical structures include e.g. sublayers of the cornea, sublayers of the retina, retinal vessels etc.
2 secondary outcomes
Corneal sublayer thickness (µm) and retinal sublayer thickness (µm) obtained with the two study instruments
Time frame: 6 months
Corneal sublayer thickness and retinal sublayer thickness obtained with the two study instruments
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2015.
- Derived from this study: PubMed 27409470Luft N, Ring MH, Dirisamer M, Mursch-Edlmayr AS, Kreutzer TC, Pretzl J, Bolz M, Priglinger SG. Corneal Epithelial Remodeling Induced by Small Incision Lenticule Extraction (SMILE). Invest Ophthalmol Vis Sci. 2016 Jul 1;57(9):OCT176-83. doi: 10.1167/iovs.15-18879.
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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.
Matthias Bolz, MD principal investigator
AKh Linz, Augenabteilung
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 Cornea and Retina, run by Augenabteilung Allgemeines Krankenhaus Linz 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 25 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 25 Nov 2015. 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 Nikolaus Luft, MD (+43 732 7806 ext. 1050, nikolaus.luft@akh.linz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity as the proportion of anatomical structures that are detectable with the two instruments (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02614625, which also lists 1 linked publication.
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 25 Nov 2015.