GlaucomaNCT00854256
Trabeculectomy Versus Canaloplasty to Treat Glaucoma
A study testing Canaloplasty and Trabeculectomy with mitomycin C in people with Glaucoma, run by University of Cologne at 1 site in Germany.
Trial summary
The aim of the study is to investigate pressure lowering effect of two surgical methods canaloplasty and trabeculectomy in patients with open angle glaucoma, in which under local pressure lowering therapy the progression of the disease could not be stopped, and thus a pressure lowering surgical intervention is… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Canaloplasty and Trabeculectomy with mitomycin C
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2009to May 2014
- 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
- patients with open angle glaucoma and excavation of 0.4 - 0.8
- 60 eyes of 60 patients (30 patients for trabeculectomy, 30 patients for Canaloplasty) The ratio of female / male is not involved.
- Eye pressure under local therapy: 20mmHg and above (corrected with pachymetry table).
- Local drug therapy: at least 2 eye pressure lowering ingredients or absolute intolerance to preservatives or eye drops.
- general anesthesia possible.
- The operation must be signed by the surgeon as a state-of-the-art performed without complication to be evaluated. If the operation does not meet this criterion, the patient is excluded from the study.
Who cannot join
- all patients are not included in the group of inclusion criteria, or:
- Phenprocoumon therapy.
- operation is not done state-of-the-art.
- after the surgery: additional eye pressure lowering surgery, cataract surgery, keratoplasty, laser surgery in the anterior eye segment (except suture lysis after trabeculectomy)
- Uveitis, or possible inflammation of the eye
- Previous eye pressure lowering operations or laser interventions
- Corneal Refractive Surgery (pseudophakia allowed)
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Centre of Ophthalmology, University of Cologne
Cologne, North Rhine-Westphalia, 50924
About this study
Official title: Comparison of Canaloplasty and Trabeculectomy in Patients With Open Angle Glaucoma and Inadequate Local Eye Pressure Lowering Therapy - a Prospective, Randomized Study
The aim of the study is to investigate pressure lowering effect of two surgical methods canaloplasty and trabeculectomy in patients with open angle glaucoma, in which under local pressure lowering therapy the progression of the disease could not be stopped, and thus a pressure lowering surgical intervention is necessary. The risks in the postoperative course in Canaloplasty in the literature as lower than for the trabeculectomy with mitomycin-C. Conversely, large glaucoma centers questioning the effectiveness of permanent pressure lowering of canaloplasty. Precisely this question is investigated in the study.
- Conditions
- Glaucoma
- Being tested
- Canaloplasty, Trabeculectomy with mitomycin C
- Keywords
- glaucoma
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CanaloplastyProcedure or surgery
Canaloplasty surgery
Trabeculectomy with mitomycin CProcedure or surgery
Trabeculectomy with mitomycin C surgery
| Study group | Role | What they receive |
|---|---|---|
| Canaloplasty | Experimental | Not described Receives: Procedure: Canaloplasty |
| Trabeculectomy with mitomycin C | Active comparator | Not described Receives: Procedure: Trabeculectomy with mitomycin C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eye pressure
Eye pressure is measured after 1 month, 2 months, 3 months, 6 months, 9 months, and 12 months after surgery.
Measured: Within 12 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2009 (estimated)
- Study startApr 2009
- Primary completionDec 2013 (estimated)
- Study completionMay 2014 (estimated)
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
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Collaborators
- iScience Interventional Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00854256
- Sponsor's protocol ID
- iScience-022-CG
- Status last verified
- Apr 2013
- First submitted
- 2 Mar 2009
- Last updated
- 15 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Canaloplasty and Trabeculectomy in Patients With Open Angle Glaucoma and Inadequate Local Eye Pressure Lowering Therapy - a Prospective, Randomized Study
- ClinicalTrials.gov ID
- NCT00854256
- Acronym / sponsor ID
- iScience-022-CG
- Conditions
- Glaucoma
- Keywords
- glaucoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Collaborators
- iScience Interventional Corporation
- Study start
- Apr 2009
- Primary completion
- Dec 2013 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 3 Mar 2009 (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 study is to investigate pressure lowering effect of two surgical methods canaloplasty and trabeculectomy in patients with open angle glaucoma, in which under local pressure lowering therapy the progression of the disease could not be stopped, and thus a pressure lowering surgical intervention is necessary. The risks in the postoperative course in Canaloplasty in the literature as lower than for the trabeculectomy with mitomycin-C. Conversely, large glaucoma centers questioning the effectiveness of permanent pressure lowering of canaloplasty. Precisely this question is investigated in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Canaloplasty | Experimental | Procedure: Canaloplasty |
| Trabeculectomy with mitomycin C | Active comparator | Procedure: Trabeculectomy with mitomycin C |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- patients with open angle glaucoma and excavation of 0.4 - 0.8
- 60 eyes of 60 patients (30 patients for trabeculectomy, 30 patients for Canaloplasty) The ratio of female / male is not involved.
- Eye pressure under local therapy: 20mmHg and above (corrected with pachymetry table).
- Local drug therapy: at least 2 eye pressure lowering ingredients or absolute intolerance to preservatives or eye drops.
- general anesthesia possible.
Key exclusion criteria (7 listed)
- all patients are not included in the group of inclusion criteria, or:
- Phenprocoumon therapy.
- operation is not done state-of-the-art.
- after the surgery: additional eye pressure lowering surgery, cataract surgery, keratoplasty, laser surgery in the anterior eye segment (except suture lysis after trabeculectomy)
- Uveitis, or possible inflammation of the 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 |
|---|---|---|
| CanaloplastyCanaloplasty surgery | Procedure or surgery | Canaloplasty |
| Trabeculectomy with mitomycin CTrabeculectomy with mitomycin C surgery | Procedure or surgery | Trabeculectomy with mitomycin C |
Primary outcome
Eye pressure
Time frame: Within 12 month after surgery
Eye pressure is measured after 1 month, 2 months, 3 months, 6 months, 9 months, and 12 months after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Canaloplasty and Trabeculectomy with mitomycin C in people with Glaucoma, 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 6 inclusion and 7 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 15 Apr 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gerhard Welsandt, MD (+49-221-478-0, g.welsandt@uni-koeln.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eye pressure (time frame: Within 12 month after surgery). 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 15 Apr 2013.