Macular EdemaNCT00564291
Evaluation of Retinal Structure With High Resolution Optical Coherence Tomography (OCT)
An observational study of Macular Edema and CNV, run by Sebastian Wolf at 2 sites in Switzerland.
Trial summary
Comparison of different OCT instruments to assess retinal thickness, correlation to fluorescein angiography, and visual outcome after therapy with anti-VEGF therapy Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Macular Edema, CNV
- What is being tested?
- Examination with an OCT device
- How many people
- 700 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Jan 2007to 28 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: healthy subjects and patients with macular diseases
Who may be able to join
- Macular disease
- Healthy subjects
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Dep. Ophthalmology, University Hospital Bern
Bern, 3010
Klinik und Poliklinik für Augenheilkunde, University Bern
Bern
About this study
Official title: Evaluation of Retinal Structure With High Resolution OCT
Comparison of different OCT instruments to assess retinal thickness, correlation to fluorescein angiography, and visual outcome after therapy with anti-VEGF therapy
Read the detailed description
Comparison of different OCT instruments to assess retinal thickness, correlation to fluorescein angiography, and visual outcome after therapy with anti-VEGF therapy
- Conditions
- Macular Edema, CNV
- Being tested
- Examination with an OCT device
- Keywords
- OCT
- Medical subject headings
- Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Examination with an OCT deviceOther
| Study group | Role | What they receive |
|---|---|---|
| 1 | Healthy volunteers Receives: Other: Examination with an OCT device | |
| 2 | CSME secondary to diabetic retinopathy | |
| 3 | ARMD with CNV before and after therapy Receives: Other: Examination with an OCT device | |
| 4 | ARMD atrophic Receives: Other: Examination with an OCT device | |
| 5 | Retinal vein occlusion Receives: Other: Examination with an OCT device | |
| 6 | retinitis pigmentosa Receives: Other: Examination with an OCT device | |
| 7 | vitreoretinal proliferation Receives: Other: Examination with an OCT device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Integrity of retinal layers
Measured: End of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2007 (estimated)
- Study startJan 2007
- Primary completion27 Nov 2023
- Study completion28 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Macular EdemaStudies 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
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sebastian Wolf
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bern
- Responsible party
- Sponsor-investigator, Sebastian Wolf, Insel Gruppe AG, University Hospital Bern
- Investigators
- Sebastian Wolf, MD, PhD, Principal investigator, University of BernSebastian Wolf, MD PhD, Study director, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00564291
- Sponsor's protocol ID
- KEK 044/07
- Status last verified
- Nov 2023
- First submitted
- 26 Nov 2007
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Lincke JB, Keller S, Amaral J, Zinkernagel MS, Schuerch K. Ciliary body length revisited by anterior segment optical coherence tomography: implications for safe access to the pars plana for intravitreal injections. Graefes Arch Clin Exp Ophthalmol. 2021 Jun;259(6):1435-1441. doi: 10.1007/s00417-020-04967-3. Epub 2020 Oct 19.
PubMed 33074373Wolf-Schnurrbusch UE, Ghanem R, Rothenbuehler SP, Enzmann V, Framme C, Wolf S. Predictors of short-term visual outcome after anti-VEGF therapy of macular edema due to central retinal vein occlusion. Invest Ophthalmol Vis Sci. 2011 May 18;52(6):3334-7. doi: 10.1167/iovs.10-6097.
PubMed 21087958Rothenbuehler SP, Waeber D, Brinkmann CK, Wolf S, Wolf-Schnurrbusch UE. Effects of ranibizumab in patients with subfoveal choroidal neovascularization attributable to age-related macular degeneration. Am J Ophthalmol. 2009 May;147(5):831-7. doi: 10.1016/j.ajo.2008.12.005. Epub 2009 Feb 13.
PubMed 19217019
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Retinal Structure With High Resolution OCT
- ClinicalTrials.gov ID
- NCT00564291
- Acronym / sponsor ID
- KEK 044/07
- Conditions
- Macular Edema, CNV
- Keywords
- OCT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- Sebastian WolfUniversity, hospital or other
- Collaborators
- University of Bern
- Study start
- Jan 2007 (actual)
- Primary completion
- 27 Nov 2023 (actual)
- Study completion
- 28 Nov 2023 (actual)
- First posted
- 27 Nov 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.
Comparison of different OCT instruments to assess retinal thickness, correlation to fluorescein angiography, and visual outcome after therapy with anti-VEGF therapy
Detailed description
Comparison of different OCT instruments to assess retinal thickness, correlation to fluorescein angiography, and visual outcome after therapy with anti-VEGF therapy
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Examination with an OCT deviceHealthy volunteers |
| 2 | – | –CSME secondary to diabetic retinopathy |
| 3 | – | Other: Examination with an OCT deviceARMD with CNV before and after therapy |
| 4 | – | Other: Examination with an OCT deviceARMD atrophic |
| 5 | – | Other: Examination with an OCT deviceRetinal vein occlusion |
| 6 | – | Other: Examination with an OCT deviceretinitis pigmentosa |
| 7 | – | Other: Examination with an OCT devicevitreoretinal proliferation |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- healthy subjects and patients with macular diseases
Key inclusion criteria (2 listed)
- Macular disease
- Healthy subjects
Key exclusion criteria (0 listed)
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 with an OCT device | Other | 1, 3, 4, 5, 6, 7 |
Primary outcome
Integrity of retinal layers
Time frame: End of study
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 29 Nov 2023.
- Derived from this study: PubMed 33074373Lincke JB, Keller S, Amaral J, Zinkernagel MS, Schuerch K. Ciliary body length revisited by anterior segment optical coherence tomography: implications for safe access to the pars plana for intravitreal injections. Graefes Arch Clin Exp Ophthalmol. 2021 Jun;259(6):1435-1441. doi: 10.1007/s00417-020-04967-3. Epub 2020 Oct 19.
- Derived from this study: PubMed 21087958Wolf-Schnurrbusch UE, Ghanem R, Rothenbuehler SP, Enzmann V, Framme C, Wolf S. Predictors of short-term visual outcome after anti-VEGF therapy of macular edema due to central retinal vein occlusion. Invest Ophthalmol Vis Sci. 2011 May 18;52(6):3334-7. doi: 10.1167/iovs.10-6097.
- Derived from this study: PubMed 19217019Rothenbuehler SP, Waeber D, Brinkmann CK, Wolf S, Wolf-Schnurrbusch UE. Effects of ranibizumab in patients with subfoveal choroidal neovascularization attributable to age-related macular degeneration. Am J Ophthalmol. 2009 May;147(5):831-7. doi: 10.1016/j.ajo.2008.12.005. Epub 2009 Feb 13.
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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.
Sebastian Wolf, MD, PhD principal investigator
University of Bern
Sebastian Wolf, MD PhD study director
University of Bern
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Macular Edema and CNV, run by Sebastian Wolf at 2 sites in Switzerland.
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 0 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 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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?
Integrity of retinal layers (time frame: End of study). 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 NCT00564291, which also lists 3 linked publications.
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 29 Nov 2023.