Retinal DiseasesNCT00437593
UHR-OCT and HD-OCT for Preretinal Membranes: ICG Versus Membrane Blue
A study testing ppVE, MP, ICG and ppVE, MP, MB in people with Retinal Diseases, run by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery at 1 site in Austria.
Trial summary
Using the UHR-OCT and HD-OCT to evaluate early postoperative changes in patients with diagnosis preretinal membrane after successfully performed pars-plana vitrectomy and membrane peeling with two different types of dyes. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Retinal Diseases
- What is being tested?
- ppVE, MP, ICG and ppVE, MP, MB
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteAustria
- Study dates
- Sep 2005to May 2008
- 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Preretinal membrane
- Age between 18 and 85 years
- Combined surgery possible(phacoemulsification and vitreoretinal procedure)
Who cannot join
- Age-related macular degeneration
- Previous retinal detachment surgery
- Previous laser treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: UHR-OCT and HD-OCT for Preretinal Membranes: Is There a Difference Between ICG and Membrane Blue? A Randomized Clinical Trial
Using the UHR-OCT and HD-OCT to evaluate early postoperative changes in patients with diagnosis preretinal membrane after successfully performed pars-plana vitrectomy and membrane peeling with two different types of dyes.
Read the detailed description
Surgical procedures performed are pars-plana vitrectomy and membrane peeling with or without cataract extraction and IOL implantation. The type of the dyes is randomized. The study is designed to include a total of tweny cases (10 cases with ICG and 10 cases with Membrane blue)
Main outcome measures are:
UHR-OCT, HD-OCT distance and near visual acuity and contrast sensitivity amsler grid secondary outcome measures are: OCT Stratus 3000 and visual field. Clinical examinations: preoperative, and follow-up examinations after 1 week, 1 months, 3 months, 6 months and 12 months.
- Conditions
- Retinal Diseases
- Being tested
- ppVE, MP, ICG, ppVE, MP, MB
- Keywords
- preretinal membrane, vitrectomy, uhr-oct, hd-oct
- Medical subject headings
- Retinal Diseases, Epiretinal Membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ppVE, MP, ICGProcedure or surgery
surgery with ILM staining
ppVE, MP, MBProcedure or surgery
Surgery with ERM staining
What is being measured
The primary outcome is the main question the study is designed to answer.
UHR-OCT HD-OCT
Measured: 12 months
Distance Visual acuity
Measured: 12 months
Near Visual acuity
Measured: 12 months
Contrast sensitivtiy
Measured: 12 months
Secondary outcomes (2)
OCT Stratus 3000
Measured: 12 months
Visual Field
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2007 (estimated)
- Study startSep 2005
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal DiseasesStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
- Sponsor type
- University, hospital or other
- Investigators
- Susanne Binder, MD, Study chair, Ludwig Boltzmann Institue for Retinology and Biomicroscopic Lasersurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00437593
- Sponsor's protocol ID
- FR-2-CI-2007
- Status last verified
- Dec 2007
- First submitted
- 19 Feb 2007
- Last updated
- 23 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UHR-OCT and HD-OCT for Preretinal Membranes: Is There a Difference Between ICG and Membrane Blue? A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00437593
- Acronym / sponsor ID
- FR-2-CI-2007
- Conditions
- Retinal Diseases
- Keywords
- preretinal membrane, vitrectomy, uhr-oct, hd-oct
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser SurgeryUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 21 Feb 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.
Using the UHR-OCT and HD-OCT to evaluate early postoperative changes in patients with diagnosis preretinal membrane after successfully performed pars-plana vitrectomy and membrane peeling with two different types of dyes.
Detailed description
Surgical procedures performed are pars-plana vitrectomy and membrane peeling with or without cataract extraction and IOL implantation. The type of the dyes is randomized. The study is designed to include a total of tweny cases (10 cases with ICG and 10 cases with Membrane blue)
Main outcome measures are:
UHR-OCT, HD-OCT distance and near visual acuity and contrast sensitivity amsler grid secondary outcome measures are: OCT Stratus 3000 and visual field. Clinical examinations: preoperative, and follow-up examinations after 1 week, 1 months, 3 months, 6 months and 12 months.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Preretinal membrane
- Age between 18 and 85 years
- Combined surgery possible(phacoemulsification and vitreoretinal procedure)
Key exclusion criteria (3 listed)
- Age-related macular degeneration
- Previous retinal detachment surgery
- Previous laser treatment
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 |
|---|---|---|
| ppVE, MP, ICGsurgery with ILM staining | Procedure or surgery | – |
| ppVE, MP, MBSurgery with ERM staining | Procedure or surgery | – |
Primary outcome
UHR-OCT HD-OCT
Time frame: 12 months
Distance Visual acuity
Time frame: 12 months
Near Visual acuity
Time frame: 12 months
Contrast sensitivtiy
Time frame: 12 months
2 secondary outcomes
OCT Stratus 3000
Time frame: 12 months
Visual Field
Time frame: 12 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 23 Sep 2008.
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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.
Susanne Binder, MD study chair
Ludwig Boltzmann Institue for Retinology and Biomicroscopic Lasersurgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ppVE, MP, ICG and ppVE, MP, MB in people with Retinal Diseases, 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 3 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 23 Sep 2008. 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?
UHR-OCT HD-OCT (time frame: 12 months). The study lists 4 primary outcomes in all. 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 23 Sep 2008.