GlaucomaTVCNCT01228799
Trabeculectomy Versus Canaloplasty
A study testing trabeculectomy and Canaloplasty in people with Glaucoma and Canaloplasty, run by University Eye Hospital, Würzburg at 1 site in Germany.
Trial summary
Study aims for comparison of trabeculectomy and canaloplasty, in order to find out if one operation is superior to the other. Both procedures are performed in patients with medically uncontrolled open-angle glaucoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Canaloplasty, Trabeculectomy
- What is being tested?
- trabeculectomy and Canaloplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2010to 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- angle closure glaucoma
- congenital glaucoma
- combined procedures (glaucoma and cataract)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Longterm Comparison Between Trabeculectomy and Canaloplasty in Open-angle Glaucoma
Study aims for comparison of trabeculectomy and canaloplasty, in order to find out if one operation is superior to the other. Both procedures are performed in patients with medically uncontrolled open-angle glaucoma. Canaloplasty is a recently newly introduced procedure, which showed encouraging results without antimetabolite usage intra- and postoperatively. Purpose of the study is to compare both surgeries concerning success rate, intraocular pressure, medication and complications. So far there is no comparison of the standard procedure trabeculectomy and the new approach, canaloplasty available.
- Conditions
- Glaucoma, Canaloplasty, Trabeculectomy
- Being tested
- trabeculectomy, Canaloplasty
- Keywords
- trabeculectomy,, canaloplasty,, glaucoma surgery, non-penetrating surgery
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trabeculectomyProcedure or surgery
trabeculectomy with mitomycin C 0.2mg/ml
CanaloplastyProcedure or surgery
Canaloplasty with implant of suture
| Study group | Role | What they receive |
|---|---|---|
| Trabeculectomy | Active comparator | Trabeculectomy with Mitomycin C Receives: Procedure: trabeculectomy |
| Canaloplasty | Active comparator | Canaloplasty with implant of suture Receives: Procedure: Canaloplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
success rate (complete and qualified success)
Success is defined 1. IOP < 21 mmHg and at least 20% IOP reduction from baseline 2. IOP < 18 mmHg
Measured: 1 year
success rate (complete and qualified success)
Success is defined 1. IOP < 21 mmHg and at least 20% IOP reduction from baseline 2. IOP < 18 mmHg
Measured: 2 years
Secondary outcomes (2)
IOP, medication, complications
intraocular pressure reduction, medication postoperatively, complications intra- and postoperatively
Measured: 1 year
IOP, medication, complications
intraocular pressure reduction, medication postoperatively, complications intra- and postoperatively
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2010 (estimated)
- Study startJun 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Eye Hospital, Würzburg
- Sponsor type
- University, hospital or other
- Investigators
- Thomas Klink, MD, Principal investigator, University Eye Hospital, Würzburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01228799
- Sponsor's protocol ID
- TVC-1
- Other IDs
- TVC
- Acronym
- TVC
- Status last verified
- Oct 2010
- First submitted
- 20 Oct 2010
- Last updated
- 19 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longterm Comparison Between Trabeculectomy and Canaloplasty in Open-angle Glaucoma
- ClinicalTrials.gov ID
- NCT01228799
- Acronym / sponsor ID
- TVC / TVC-1
- Conditions
- Glaucoma, Canaloplasty, Trabeculectomy
- Keywords
- trabeculectomy,, canaloplasty,, glaucoma surgery, non-penetrating surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University Eye Hospital, WürzburgUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 27 Oct 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.
Study aims for comparison of trabeculectomy and canaloplasty, in order to find out if one operation is superior to the other. Both procedures are performed in patients with medically uncontrolled open-angle glaucoma. Canaloplasty is a recently newly introduced procedure, which showed encouraging results without antimetabolite usage intra- and postoperatively. Purpose of the study is to compare both surgeries concerning success rate, intraocular pressure, medication and complications. So far there is no comparison of the standard procedure trabeculectomy and the new approach, canaloplasty available.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trabeculectomy | Active comparator | Procedure: trabeculectomyTrabeculectomy with Mitomycin C |
| Canaloplasty | Active comparator | Procedure: CanaloplastyCanaloplasty with implant of suture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- angle closure glaucoma
- congenital glaucoma
- combined procedures (glaucoma and cataract)
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 |
|---|---|---|
| trabeculectomytrabeculectomy with mitomycin C 0.2mg/ml | Procedure or surgery | Trabeculectomy |
| CanaloplastyCanaloplasty with implant of suture | Procedure or surgery | Canaloplasty |
Primary outcome
success rate (complete and qualified success)
Time frame: 1 year
Success is defined 1. IOP < 21 mmHg and at least 20% IOP reduction from baseline 2. IOP < 18 mmHg
success rate (complete and qualified success)
Time frame: 2 years
Success is defined 1. IOP < 21 mmHg and at least 20% IOP reduction from baseline 2. IOP < 18 mmHg
2 secondary outcomes
IOP, medication, complications
Time frame: 1 year
IOP, medication, complications
Time frame: 2 years
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 19 Aug 2013.
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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.
Thomas Klink, MD principal investigator
University Eye Hospital, Würzburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing trabeculectomy and Canaloplasty in people with Glaucoma and Canaloplasty, run by University Eye Hospital, Würzburg 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 0 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 19 Aug 2013. 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.
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?
success rate (complete and qualified success) (time frame: 1 year). 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 19 Aug 2013.