Macular PuckerPhase 3NCT01083004
Brilliant Blue Versus Indocyanine Green
A Phase 3 study testing Indocyanine green and Brilliant blue arm in people with Macular Pucker and Macular Hole, run by University of Cologne at 1 site in Germany.
Trial summary
A study of non-inferiority design comparing brilliant blue and indocyanine green as intraoperative dye in macular pucker and macular hole. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Macular Pucker, Macular Hole, Vitreoretinal Surgery
- What is being tested?
- Indocyanine green and Brilliant blue arm
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2008to May 2011
- Phase
- Phase 3
- 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
Who may be able to join
- age over 50
- macular pucker or macular hole with subjective disturbances
- All phakic or pseudophakic patients
- far visual acuity better than 20/400
- able to read, understand, and willing to sign the informed consent form
Who cannot join
- any other ocular disease or conditions compromising the visual acuity other than macular hole or macular pucker
- prior vitreoretinal surgery in the study eye
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Center of Ophthalmology, University of Cologne
Cologne, North Rhine-Westphalia, 50924
Albert Caramoy, MD, 004902214784308, acaramoy@yahoo.co.uk
Albert Caramoy, MD
About this study
Official title: A Randomized Study Comparing Brilliant Blue and Indocyanine Green as Intravitreal Dye in Macular Pucker and Macular Hole
A study of non-inferiority design comparing brilliant blue and indocyanine green as intraoperative dye in macular pucker and macular hole.
- Conditions
- Macular Pucker, Macular Hole, Vitreoretinal Surgery
- Being tested
- Indocyanine green, Brilliant blue arm
- Keywords
- dye, internal limiting membrane, macular hole, macular pucker
- 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.
Indocyanine greenProcedure or surgery
Using indocyanine green as intraoperative dye
Brilliant blue armProcedure or surgery
Using brilliant blue as intraoperative dye
| Study group | Role | What they receive |
|---|---|---|
| Indocyanine green arm | Active comparator | Not described Receives: Procedure: Indocyanine green |
| Brilliant blue | Active comparator | Not described Receives: Procedure: Brilliant blue arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best corrected far visual acuity (ETDRS)
Measured: 1 year postoperative
Secondary outcomes (2)
Reading ability (Radner)
Measured: 1 Year
Optical coherence tomography
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2010 (estimated)
- Study startJan 2008
- Primary completionMay 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Investigators
- Bernd Kirchhof, MD, Principal investigator, University of Cologne, Center of Ophthalmology, 50924 Cologne, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01083004
- Sponsor's protocol ID
- BlueIce001
- Status last verified
- Oct 2007
- First submitted
- 8 Mar 2010
- Last updated
- 18 Apr 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study Comparing Brilliant Blue and Indocyanine Green as Intravitreal Dye in Macular Pucker and Macular Hole
- ClinicalTrials.gov ID
- NCT01083004
- Acronym / sponsor ID
- BlueIce001
- Conditions
- Macular Pucker, Macular Hole, Vitreoretinal Surgery
- Keywords
- dye, internal limiting membrane, macular hole, macular pucker
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- May 2011 (estimated)
- First posted
- 9 Mar 2010 (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.
A study of non-inferiority design comparing brilliant blue and indocyanine green as intraoperative dye in macular pucker and macular hole.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Indocyanine green arm | Active comparator | Procedure: Indocyanine green |
| Brilliant blue | Active comparator | Procedure: Brilliant blue arm |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age over 50
- macular pucker or macular hole with subjective disturbances
- All phakic or pseudophakic patients
- far visual acuity better than 20/400
- able to read, understand, and willing to sign the informed consent form
Key exclusion criteria (2 listed)
- any other ocular disease or conditions compromising the visual acuity other than macular hole or macular pucker
- prior vitreoretinal surgery in the study eye
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 |
|---|---|---|
| Indocyanine greenUsing indocyanine green as intraoperative dye | Procedure or surgery | Indocyanine green arm |
| Brilliant blue armUsing brilliant blue as intraoperative dye | Procedure or surgery | Brilliant blue |
Primary outcome
Best corrected far visual acuity (ETDRS)
Time frame: 1 year postoperative
2 secondary outcomes
Reading ability (Radner)
Time frame: 1 Year
Optical coherence tomography
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2011.
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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.
Bernd Kirchhof, MD principal investigator
University of Cologne, Center of Ophthalmology, 50924 Cologne, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Indocyanine green and Brilliant blue arm in people with Macular Pucker and Macular Hole, run by University of Cologne at 1 site in Germany.
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 5 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: status not confirmed, as of the sponsor's last update on 18 Apr 2011. 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 Germany. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Albert Caramoy, MD (004902214784308, acaramoy@yahoo.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best corrected far visual acuity (ETDRS) (time frame: 1 year postoperative). 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 18 Apr 2011.