Macular PuckerNCT00555269
Membrane Blue Versus Infracyanine Green
An observational study of Macular Pucker and Macular Hole, run by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery.
Trial summary
To compare possible toxicities of membrane blue and infracyanine green in vivo by macular function and peripheral visual field. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Macular Pucker, Macular Hole
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Oct 2004to Dec 2005
- 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a macular pucker or a macular hole, without any other retinal disease
Who may be able to join
- Macular pucker or macular hole
Who cannot join
- Any other retinal disease
About this study
Official title: Comparison of Macular Function and Visual Fields After Membrane Blue or Infracyanine Green Staining in Vitreoretinal Surgery
To compare possible toxicities of membrane blue and infracyanine green in vivo by macular function and peripheral visual field.
- Conditions
- Macular Pucker, Macular Hole
- Keywords
- Macular pucker, Macular hole, Membrane Blue, Infracyanine Green, Peripheral Visual Field
- Medical subject headings
- Epiretinal Membrane, Retinal Perforations
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 |
|---|---|---|
| MB | Not described | |
| IFCG | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity, macular thickness and peripheral visual field
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2007 (estimated)
- Study startOct 2004
- Study completionDec 2005
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 PuckerStudies 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
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
- Sponsor type
- University, hospital or other
- Investigators
- Katharina E Schmid-Kubista, MD, Principal investigator, Ludwig Boltzmann Institute for Retinology and Biomicroscopic Lasersurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00555269
- Sponsor's protocol ID
- MB vs IFCG
- Status last verified
- Apr 2009
- First submitted
- 7 Nov 2007
- Last updated
- 22 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Schmid-Kubista KE, Lamar PD, Schenk A, Stolba U, Binder S. Comparison of macular function and visual fields after membrane blue or infracyanine green staining in vitreoretinal surgery. Graefes Arch Clin Exp Ophthalmol. 2010 Mar;248(3):381-8. doi: 10.1007/s00417-009-1213-4. Epub 2009 Oct 13.
PubMed 19823863
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Macular Function and Visual Fields After Membrane Blue or Infracyanine Green Staining in Vitreoretinal Surgery
- ClinicalTrials.gov ID
- NCT00555269
- Acronym / sponsor ID
- MB vs IFCG
- Conditions
- Macular Pucker, Macular Hole
- Keywords
- Macular pucker, Macular hole, Membrane Blue, Infracyanine Green, Peripheral Visual Field
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser SurgeryUniversity, hospital or other
- Study start
- Oct 2004
- Study completion
- Dec 2005 (actual)
- First posted
- 8 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.
To compare possible toxicities of membrane blue and infracyanine green in vivo by macular function and peripheral visual field.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MB | – | – |
| IFCG | – | – |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a macular pucker or a macular hole, without any other retinal disease
Key inclusion criteria (1 listed)
- Macular pucker or macular hole
Key exclusion criteria (1 listed)
- Any other retinal 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
Visual acuity, macular thickness and peripheral visual field
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 Apr 2009.
- Derived from this study: PubMed 19823863Schmid-Kubista KE, Lamar PD, Schenk A, Stolba U, Binder S. Comparison of macular function and visual fields after membrane blue or infracyanine green staining in vitreoretinal surgery. Graefes Arch Clin Exp Ophthalmol. 2010 Mar;248(3):381-8. doi: 10.1007/s00417-009-1213-4. Epub 2009 Oct 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.
Katharina E Schmid-Kubista, MD principal investigator
Ludwig Boltzmann Institute for Retinology and Biomicroscopic Lasersurgery
Questions about this trial
What is this clinical trial studying?
An observational study of Macular Pucker and Macular Hole, run by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery.
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 1 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 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
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, macular thickness and peripheral visual field. 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 NCT00555269, 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 Apr 2009.