Macular EdemaNCT01603823
Angiographie and OCT in Macula and Retinal Diseases
An observational study of Macular Edema, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The purpose of this study is to investigate the morphological and angiological retinal changes in different macular diseases. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Macular Edema
- How many people
- 30 participants
- Where
- 1 siteAustria
- Study dates
- Aug 2008to Sep 2011
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Twenty eyes of 20 patients with previous 23-gauge PPV and ILM peeling (PPV group) and 15 consecutive eyes with senile cataract with a healthy macula (control group) were included.
Who may be able to join
- previous 23-gauge PPV and ILM peeling
Who cannot join
- history of branch retinal vein occlusion
- central retinal vein occlusion
- wet macular degeneration
- diabetic retinopathy
- uveitis or other inflammatory eye disease.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate the morphological and angiological retinal changes in different macular diseases.
Read the detailed description
Recently, a new generation of OCT devices relying on spectral domain technology (SD-OCT) has been introduced and allows for higher-resolution imaging. Based on this technology we can identify variable changes at the retinal surface such as, retinal thickening with cyst formation, swelling in the inner and outer nuclear layers and subretinal fluid. The introduction of an eye-tracking mode has allowed a better insight into the development of retinal morphologic changes The aim of this study was to investigate the incidence and structural morphology of PCME after successful uncomplicated cataract surgery in patients with previous pars plana vitrectomy (PPV) and indocyanine green-assisted peeling of an epiretinal membrane and the internal limiting membrane (ILM).
- Conditions
- Macular Edema
- Keywords
- vitrectomy, cataract, macular edema
- Medical subject headings
- Macular Edema, Cataract
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 |
|---|---|---|
| Healthy volunteers | Not described | |
| St.p. Pars plana vitrectomy | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2012 (estimated)
- Study startAug 2008
- Primary completionFeb 2010
- Study completionSep 2011
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 EdemaStudies 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 (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefan Sacu, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01603823
- Sponsor's protocol ID
- 10082007
- Status last verified
- May 2012
- First submitted
- 19 May 2012
- Last updated
- 22 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mylonas G, Sacu S, Deak G, Dunavoelgyi R, Buehl W, Georgopoulos M, Schmidt-Erfurth U; Macula Study Group Vienna. Macular edema following cataract surgery in eyes with previous 23-gauge vitrectomy and peeling of the internal limiting membrane. Am J Ophthalmol. 2013 Feb;155(2):253-259.e2. doi: 10.1016/j.ajo.2012.07.013. Epub 2012 Oct 1.
PubMed 23036567
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Angiographie and OCT in Macula and Retinal Diseases
- ClinicalTrials.gov ID
- NCT01603823
- Acronym / sponsor ID
- 10082007
- Conditions
- Macular Edema
- Keywords
- vitrectomy, cataract, macular edema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 22 May 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.
The purpose of this study is to investigate the morphological and angiological retinal changes in different macular diseases.
Detailed description
Recently, a new generation of OCT devices relying on spectral domain technology (SD-OCT) has been introduced and allows for higher-resolution imaging. Based on this technology we can identify variable changes at the retinal surface such as, retinal thickening with cyst formation, swelling in the inner and outer nuclear layers and subretinal fluid. The introduction of an eye-tracking mode has allowed a better insight into the development of retinal morphologic changes The aim of this study was to investigate the incidence and structural morphology of PCME after successful uncomplicated cataract surgery in patients with previous pars plana vitrectomy (PPV) and indocyanine green-assisted peeling of an epiretinal membrane and the internal limiting membrane (ILM).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | – |
| St.p. Pars plana vitrectomy | – | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Twenty eyes of 20 patients with previous 23-gauge PPV and ILM peeling (PPV group) and 15 consecutive eyes with senile cataract with a healthy macula (control group) were included.
Key inclusion criteria (1 listed)
- previous 23-gauge PPV and ILM peeling
Key exclusion criteria (5 listed)
- history of branch retinal vein occlusion
- central retinal vein occlusion
- wet macular degeneration
- diabetic retinopathy
- uveitis or other inflammatory eye disease.
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
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 22 May 2012.
- Derived from this study: PubMed 23036567Mylonas G, Sacu S, Deak G, Dunavoelgyi R, Buehl W, Georgopoulos M, Schmidt-Erfurth U; Macula Study Group Vienna. Macular edema following cataract surgery in eyes with previous 23-gauge vitrectomy and peeling of the internal limiting membrane. Am J Ophthalmol. 2013 Feb;155(2):253-259.e2. doi: 10.1016/j.ajo.2012.07.013. Epub 2012 Oct 1.
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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?
An observational study of Macular Edema, 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 1 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 22 May 2012. 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 NCT01603823, 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 22 May 2012.