Diabetic RetinopathyPhase 4NCT00411970
20- Versus 23- Gauge System for Pars Plana Vitrectomy
A Phase 4 study testing 20- and 23 gauge vitreoretinal surgery systems in people with Diabetic Retinopathy and Macular Edema, run by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery at 1 site in Austria.
Trial summary
The aim of the present study is to compare the functional and clinical differences and advantages between a standard operating system and a newly developed even smaller system for pars plana vitrectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy, Macular Edema, Postoperative Complications
- What is being tested?
- 20- and 23 gauge vitreoretinal surgery systems
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteAustria
- Study dates
- Sep 2004to Oct 2007
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years of age
- Written form of consent
- Vitreous and retinal pathologies requiring surgery
Who cannot join
- Previous history of vitreous or retinal surgery
- Pregnant or breastfeeding women
- Prohibiting general medical conditions or diseases
- No informed consent signed
- Under 18 years of age
Trial locations and contacts
1 site in 1 country.
Austria1 site
Ludwig Boltzmann Institute for Retinology and Biomicroscopic Laser Surgery
Vienna, 1030
About this study
Official title: 20- Versus 23- Gauge System for Pars Plana Vitrectomy: A Prospective Randomized Clinical Study
The aim of the present study is to compare the functional and clinical differences and advantages between a standard operating system and a newly developed even smaller system for pars plana vitrectomy.
The present study may work out the possible advantages and disadvantages between the routinely used 20-gauge vitrectomy system and the newly developed 23-gauge device.
Read the detailed description
60 patient randomized into 2 groups of 30 each. All of them operated in general anesthesia, vitrectomized and cataract extracted by phacoemulsification if indicated. Preoperative and postoper5ative controls at days 1,2,3 and week 1, month 1,3 and 12 performed. Parameters of interest are: postoperative conjunctival injection, pain, eye pressure, complications intra- and postoperative as well as the durations of surgery divided into opening time, vitrectomy time, retinal manipulation time, closing time.
- Being tested
- 20- and 23 gauge vitreoretinal surgery systems
- Keywords
- 23 gauge pars plana vitrectomy, conjunctival erythema and injection, 20 gauge pars plana vitrectomy, vitreous and retinal surgery
- Medical subject headings
- Diabetic Retinopathy, Macular Edema, Postoperative Complications, Vitreous Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20- and 23 gauge vitreoretinal surgery systemsDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Conjunctival Injection
Subjective postoperative recovery
Secondary outcomes (5)
Surgery time
Intraocular pressure
Visual acuity
Technically successful surgery (from surgeon's view)
Intra- and postoperative complications
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2006 (estimated)
- Study startSep 2004
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- 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
- Investigators
- Susanne Binder, Prof. MD, Principal investigator, Ludwig Boltzmann Institute for Retinology and Biomicroscopic Laser SurgeryLukas M Kellner, MD, Study director, Ludwig Boltzmann Institute for Retinology and Biomicroscopic Laser SurgeryBarbara Wimpissinger, MD, Study chair, Ludwig Boltzmann Institute for Retinology and Biomicroscopic Laser Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00411970
- Sponsor's protocol ID
- 23 versus 20 gauge
- Status last verified
- Oct 2007
- First submitted
- 14 Dec 2006
- Last updated
- 25 Oct 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 20- Versus 23- Gauge System for Pars Plana Vitrectomy: A Prospective Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT00411970
- Acronym / sponsor ID
- 23 versus 20 gauge
- Keywords
- 23 gauge pars plana vitrectomy, conjunctival erythema and injection, 20 gauge pars plana vitrectomy, vitreous and retinal surgery
- Phase
- Phase 4
- 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
- Sep 2004
- Study completion
- Oct 2007 (actual)
- First posted
- 15 Dec 2006 (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.
The aim of the present study is to compare the functional and clinical differences and advantages between a standard operating system and a newly developed even smaller system for pars plana vitrectomy.
The present study may work out the possible advantages and disadvantages between the routinely used 20-gauge vitrectomy system and the newly developed 23-gauge device.
Detailed description
60 patient randomized into 2 groups of 30 each. All of them operated in general anesthesia, vitrectomized and cataract extracted by phacoemulsification if indicated. Preoperative and postoper5ative controls at days 1,2,3 and week 1, month 1,3 and 12 performed. Parameters of interest are: postoperative conjunctival injection, pain, eye pressure, complications intra- and postoperative as well as the durations of surgery divided into opening time, vitrectomy time, retinal manipulation time, closing time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 18 years of age
- Written form of consent
- Vitreous and retinal pathologies requiring surgery
Key exclusion criteria (5 listed)
- Previous history of vitreous or retinal surgery
- Pregnant or breastfeeding women
- Prohibiting general medical conditions or diseases
- No informed consent signed
- Under 18 years of age
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 |
|---|---|---|
| 20- and 23 gauge vitreoretinal surgery systems | Device | – |
Primary outcome
Conjunctival Injection
Subjective postoperative recovery
5 secondary outcomes
Surgery time
Intraocular pressure
Visual acuity
Technically successful surgery (from surgeon's view)
Intra- and postoperative complications
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 25 Oct 2007.
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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, Prof. MD principal investigator
Ludwig Boltzmann Institute for Retinology and Biomicroscopic Laser Surgery
Lukas M Kellner, MD study director
Ludwig Boltzmann Institute for Retinology and Biomicroscopic Laser Surgery
Barbara Wimpissinger, MD study chair
Ludwig Boltzmann Institute for 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 Phase 4 study testing 20- and 23 gauge vitreoretinal surgery systems in people with Diabetic Retinopathy and Macular Edema, 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 5 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 25 Oct 2007. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Conjunctival Injection. The study lists 2 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 25 Oct 2007.