Rhegmatogenous Retinal DetachmentNCT00757536
Primary Vitrectomy With Endolaser or Encircling Band for Rhegmatogenous Retinal Detachment
A study testing Encircling Band and Endolaser Photocoagulation in people with Rhegmatogenous Retinal Detachment and Primary Vitrectomy, run by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery at 1 site in Austria.
Trial summary
Comparing primary PPV with 360° endolaser photocoagulation with primary PPV with an encircling band for patients with RRDs. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rhegmatogenous Retinal Detachment, Primary Vitrectomy, Encircling Band
- What is being tested?
- Encircling Band and Endolaser Photocoagulation
- 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
- May 2006to Dec 2012
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Primary rhegmatogenous retinal detachment with or without macula-off detachment phakic or pseudophakic eyes
- Multiple breaks, inferior and posterior located breaks or unclear hole formation
- Proliferative vitreoretinopathy (PVR) stage A and B
Who cannot join
- Previous retinal detachment surgery
- Giant tears
- PVR stage C
- Age less than 18 years
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: Primary Vitrectomy Combined With 360° Endolaser or Encircling Band for Rhegmatogenous Retinal Detachment (V.E.E. Study)
Comparing primary PPV with 360° endolaser photocoagulation with primary PPV with an encircling band for patients with RRDs.
Read the detailed description
published
- Conditions
- Rhegmatogenous Retinal Detachment, Primary Vitrectomy, Encircling Band, Endolaser Treatment
- Being tested
- Encircling Band, Endolaser Photocoagulation
- Keywords
- Rhegmatogenous retinal detachment, primary vitrectomy, encircling band, endolaser treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Encircling BandProcedure or surgery
ppVE and encircling band
Endolaser PhotocoagulationProcedure or surgery
ppVE and endolaser photocoagulation
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Not described Receives: Procedure: Encircling Band |
| Group 2 | Active comparator | Not described Receives: Procedure: Endolaser Photocoagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal redetachment rate
Measured: 6 months
Secondary outcomes (1)
Surgery-related complications, patients' comfort, refractive change, visual acuity and optical coherence tomography.
Measured: 6 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 startMay 2006
- Primary completionDec 2012
- Study completionDec 2012
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 Rhegmatogenous Retinal DetachmentStudies 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
- None (open label)
- 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
- Susanne Binder, MD, Study chair, The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser SurgeryChristiane I Falkner-Radler, MD, Principal investigator, The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00757536
- Sponsor's protocol ID
- FR-3-CI-2008
- Status last verified
- Jan 2016
- First submitted
- 21 Sep 2008
- Last updated
- 26 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Falkner-Radler CI, Graf A, Binder S. Vitrectomy combined with endolaser or an encircling scleral buckle in primary retinal detachment surgery: a pilot study. Acta Ophthalmol. 2015 Aug;93(5):464-469. doi: 10.1111/aos.12663. Epub 2015 Jan 28.
PubMed 25626910
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
- Primary Vitrectomy Combined With 360° Endolaser or Encircling Band for Rhegmatogenous Retinal Detachment (V.E.E. Study)
- ClinicalTrials.gov ID
- NCT00757536
- Acronym / sponsor ID
- FR-3-CI-2008
- Conditions
- Rhegmatogenous Retinal Detachment, Primary Vitrectomy, Encircling Band, Endolaser Treatment
- Keywords
- Rhegmatogenous retinal detachment, primary vitrectomy, encircling band, endolaser treatment
- 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
- May 2006
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (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.
Comparing primary PPV with 360° endolaser photocoagulation with primary PPV with an encircling band for patients with RRDs.
Detailed description
published
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Procedure: Encircling Band |
| Group 2 | Active comparator | Procedure: Endolaser Photocoagulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primary rhegmatogenous retinal detachment with or without macula-off detachment phakic or pseudophakic eyes
- Multiple breaks, inferior and posterior located breaks or unclear hole formation
- Proliferative vitreoretinopathy (PVR) stage A and B
Key exclusion criteria (4 listed)
- Previous retinal detachment surgery
- Giant tears
- PVR stage C
- Age less than 18 years
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 |
|---|---|---|
| Encircling BandppVE and encircling band | Procedure or surgery | Group 1 |
| Endolaser PhotocoagulationppVE and endolaser photocoagulation | Procedure or surgery | Group 2 |
Primary outcome
Retinal redetachment rate
Time frame: 6 months
1 secondary outcome
Surgery-related complications, patients' comfort, refractive change, visual acuity and optical coherence tomography.
Time frame: 6 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.
- Derived from this study: PubMed 25626910Falkner-Radler CI, Graf A, Binder S. Vitrectomy combined with endolaser or an encircling scleral buckle in primary retinal detachment surgery: a pilot study. Acta Ophthalmol. 2015 Aug;93(5):464-469. doi: 10.1111/aos.12663. Epub 2015 Jan 28.
- Individual participant dataSharing planned: No
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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
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Christiane I Falkner-Radler, MD 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 Encircling Band and Endolaser Photocoagulation in people with Rhegmatogenous Retinal Detachment and Primary Vitrectomy, 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 4 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?
Retinal redetachment rate (time frame: 6 months). 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 NCT00757536, 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 26 Jan 2016.