Idiopathic Epiretinal MembranesNCT00757380
Trypan Blue Versus Brillant Blue for Epiretinal Membranes
A study testing Trypan Blue and Brillant Blue in people with Idiopathic Epiretinal Membranes, run by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery at 1 site in Austria.
Trial summary
Membraneppeling alone versus Membranepeeling with Membrane Limitans Interna Pelling using two different Dyes for Epiretinal Membrane Surgery. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Epiretinal Membranes
- What is being tested?
- Trypan Blue and Brillant Blue
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteAustria
- Study dates
- Jul 2008to Aug 2015
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Idiopathic eperetinal membranes
- Phakic or pseudophakic eyes
- Age over 60 years
Who cannot join
- Secondary epiretinal membranes
- Severe ocular pathologies
Trial locations and contacts
1 site in 1 country.
Austria1 site
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Vienna, State of Vienna, 1030
About this study
Official title: Membranepeeling With Trypan Blue Versus Membranpeeling With Brillant Blue for Patients With Idiopathic Epiretinal Membranes
Membraneppeling alone versus Membranepeeling with Membrane Limitans Interna Pelling using two different Dyes for Epiretinal Membrane Surgery.
- Conditions
- Idiopathic Epiretinal Membranes
- Being tested
- Trypan Blue, Brillant Blue
- Keywords
- epiretinal membranes, vitreoretinal dyes, membranepeeling
- Medical subject headings
- Epiretinal Membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trypan BlueProcedure or surgery
Membranepeeling with TB
Brillant BlueProcedure or surgery
Membranepeeling and membrana limitans interna peeling with BB
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Trypan Blue Receives: Procedure: Trypan Blue |
| Group 2 | Active comparator | Brillant Blue Receives: Procedure: Brillant Blue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
Measured: 3 months
Secondary outcomes (1)
Microperimetry optical coherence tomographie questionnaire (metamorphopsien)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2008 (estimated)
- Study startJul 2008
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Epiretinal MembranesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Christiane I. Falkner-Radler, The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
- Investigators
- Katharina Kreppler, Univ. Doz. Dr., Study chair, The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser SurgeryChristiane I Falkner-Radler, Dr., Principal investigator, The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00757380
- Sponsor's protocol ID
- FR-4-CI-2008
- Status last verified
- Jan 2016
- First submitted
- 21 Sep 2008
- Last updated
- 26 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Membranepeeling With Trypan Blue Versus Membranpeeling With Brillant Blue for Patients With Idiopathic Epiretinal Membranes
- ClinicalTrials.gov ID
- NCT00757380
- Acronym / sponsor ID
- FR-4-CI-2008
- Conditions
- Idiopathic Epiretinal Membranes
- Keywords
- epiretinal membranes, vitreoretinal dyes, membranepeeling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser SurgeryUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 23 Sep 2008 (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.
Membraneppeling alone versus Membranepeeling with Membrane Limitans Interna Pelling using two different Dyes for Epiretinal Membrane Surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Procedure: Trypan BlueTrypan Blue |
| Group 2 | Active comparator | Procedure: Brillant BlueBrillant Blue |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Idiopathic eperetinal membranes
- Phakic or pseudophakic eyes
- Age over 60 years
Key exclusion criteria (2 listed)
- Secondary epiretinal membranes
- Severe ocular pathologies
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 |
|---|---|---|
| Trypan BlueMembranepeeling with TB | Procedure or surgery | Group 1 |
| Brillant BlueMembranepeeling and membrana limitans interna peeling with BB | Procedure or surgery | Group 2 |
Primary outcome
Visual acuity
Time frame: 3 months
1 secondary outcome
Microperimetry optical coherence tomographie questionnaire (metamorphopsien)
Time frame: 3 months
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 26 Jan 2016.
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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.
Katharina Kreppler, Univ. Doz. Dr. study chair
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Christiane I Falkner-Radler, Dr. principal investigator
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trypan Blue and Brillant Blue in people with Idiopathic Epiretinal Membranes, 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 3 inclusion and 2 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 26 Jan 2016. 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?
Visual acuity (time frame: 3 months). 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 26 Jan 2016.