Macular DegenerationNCT00531141
The Optical Coherence Tomography in Age-Related Macular Degeneration Study: The OCT in AMD Study
An observational study of Macular Degeneration, run by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery at 1 site in Austria.
Trial summary
The Optical Coherence Tomography (OCT) is a non-contact, non invasive method to examine the retina by providing cross-sectional scans through the retina. Measurements of the retinal thickness based on automatically set border lines created by threshold algorithm provide information concerning the amount of… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Macular Degeneration
- What is being tested?
- examination only
- How many people
- 200 participants
- Where
- 1 siteAustria
- Study dates
- May 2007to Jun 2008
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: primary care clinic
Who may be able to join
- Age over 50 years
- Age related macular degeneration
Who cannot join
- Macular pathologies other than age related macular degeneration (diabetic maculopathy, macular pucker, macular hole,
- Visualization of the macula not possible (dens cataract, vitreous haemorrhage)
- Not consented patients
Trial locations and contacts
1 site in 1 country.
Austria1 site
Ludwig Boltzmann Institute for Retinology and Biomicroscopic Lasersurgery
Vienna, State of Vienna, A1030
About this study
Official title: Reproducibility of Retinal Thickness Measurements by Optical Coherence Tomography in Age-Related Macular Degeneration The OCT in AMD Study
The Optical Coherence Tomography (OCT) is a non-contact, non invasive method to examine the retina by providing cross-sectional scans through the retina. Measurements of the retinal thickness based on automatically set border lines created by threshold algorithm provide information concerning the amount of intraretinal fluid and activity of the lesion. In this study the reproducibility of retinal thickness measurements in patients suffering from age-related macular degeneration performed by two independent examiners of two examinations of the same day but performed in a time interval of at least two hours should be evaluated. Using the macular thickness program of stratus OCT, 6 radial lines through the center of the foveal avascular zone are performed, Differences between the first and second measurement will be investigated by a 95% confidence interval, a Bland-Altman plot (with corresponding regression analysis) and a random effect model with time, examiner and diagnosis as fixed factors. Although threshold algorithm failures and fixation problems are common in age-related macular degeneration evidence of reproducibility and repeatability of maximum retinal thickness is expected.
- Conditions
- Macular Degeneration
- Being tested
- examination only
- Keywords
- age-related macular degeneration, optical coherence tomography, retinal thickness, exudative age-related macular degeneration
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
examination onlyOther
OCT performed twice
| Study group | Role | What they receive |
|---|---|---|
| A | examination twice by examiner 1 Receives: Other: examination only | |
| B | examination first by examiner 1 thereafter by examiner 2 Receives: Other: examination only | |
| C | examination first by examiner 2 thereafter by examiner 1 Receives: Other: examination only | |
| D | examination performed twice by examiner 2 Receives: Other: examination only |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2007 (estimated)
- Study startMay 2007
- Primary completionJun 2008
- Study completionJun 2008
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 Macular DegenerationStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
- Sponsor type
- University, hospital or other
- Investigators
- Ilse Krebs, MD, Principal investigator, Rudolf Foundation Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00531141
- Sponsor's protocol ID
- EK 07-078-VK
- Status last verified
- Jun 2009
- First submitted
- 15 Sep 2007
- Last updated
- 24 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Krebs I, Hagen S, Brannath W, Haas P, Womastek I, de Salvo G, Ansari-Shahrezaei S, Binder S. Repeatability and reproducibility of retinal thickness measurements by optical coherence tomography in age-related macular degeneration. Ophthalmology. 2010 Aug;117(8):1577-84. doi: 10.1016/j.ophtha.2010.04.032. Epub 2010 Jun 16.
PubMed 20557937
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reproducibility of Retinal Thickness Measurements by Optical Coherence Tomography in Age-Related Macular Degeneration The OCT in AMD Study
- ClinicalTrials.gov ID
- NCT00531141
- Acronym / sponsor ID
- EK 07-078-VK
- Conditions
- Macular Degeneration
- Keywords
- age-related macular degeneration, optical coherence tomography, retinal thickness, exudative age-related macular degeneration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser SurgeryUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 18 Sep 2007 (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.
The Optical Coherence Tomography (OCT) is a non-contact, non invasive method to examine the retina by providing cross-sectional scans through the retina. Measurements of the retinal thickness based on automatically set border lines created by threshold algorithm provide information concerning the amount of intraretinal fluid and activity of the lesion. In this study the reproducibility of retinal thickness measurements in patients suffering from age-related macular degeneration performed by two independent examiners of two examinations of the same day but performed in a time interval of at least two hours should be evaluated. Using the macular thickness program of stratus OCT, 6 radial lines through the center of the foveal avascular zone are performed, Differences between the first and second measurement will be investigated by a 95% confidence interval, a Bland-Altman plot (with corresponding regression analysis) and a random effect model with time, examiner and diagnosis as fixed factors. Although threshold algorithm failures and fixation problems are common in age-related macular degeneration evidence of reproducibility and repeatability of maximum retinal thickness is expected.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | – | Other: examination onlyexamination twice by examiner 1 |
| B | – | Other: examination onlyexamination first by examiner 1 thereafter by examiner 2 |
| C | – | Other: examination onlyexamination first by examiner 2 thereafter by examiner 1 |
| D | – | Other: examination onlyexamination performed twice by examiner 2 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (2 listed)
- Age over 50 years
- Age related macular degeneration
Key exclusion criteria (3 listed)
- Macular pathologies other than age related macular degeneration (diabetic maculopathy, macular pucker, macular hole,
- Visualization of the macula not possible (dens cataract, vitreous haemorrhage)
- Not consented patients
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 |
|---|---|---|
| examination onlyOCT performed twice | Other | A, B, C, D |
Primary outcome
Not reported in the source record.
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 24 Jun 2009.
- Derived from this study: PubMed 20557937Krebs I, Hagen S, Brannath W, Haas P, Womastek I, de Salvo G, Ansari-Shahrezaei S, Binder S. Repeatability and reproducibility of retinal thickness measurements by optical coherence tomography in age-related macular degeneration. Ophthalmology. 2010 Aug;117(8):1577-84. doi: 10.1016/j.ophtha.2010.04.032. Epub 2010 Jun 16.
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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.
Ilse Krebs, MD principal investigator
Rudolf Foundation Clinic
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 Macular Degeneration, run by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery 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 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: finished, as of the sponsor's last update on 24 Jun 2009. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00531141, 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 24 Jun 2009.