Trabeculectomy Versus Canaloplasty (TVC)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by University Eye Hospital, Würzburg.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University Eye Hospital, Würzburg
Information provided by:
University Eye Hospital, Würzburg
ClinicalTrials.gov Identifier:
NCT01228799
First received: October 20, 2010
Last updated: October 26, 2010
Last verified: October 2010
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| First Received Date ICMJE | October 20, 2010 | ||||||||
| Last Updated Date | October 26, 2010 | ||||||||
| Start Date ICMJE | June 2010 | ||||||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01228799 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Trabeculectomy Versus Canaloplasty | ||||||||
| Official Title ICMJE | Longterm Comparison Between Trabeculectomy and Canaloplasty in Open-angle Glaucoma | ||||||||
| Brief 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. 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 60 | ||||||||
| Completion Date | Not Provided | ||||||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:1. diagnosed primary or secondary open-angle glaucoma 2. IOP > 16 mmHg (<60 days prior surgery) 3. IOP > 21 mmHg 4. no prior glaucoma surgery (once laser trabeculoplasty or cyclophotocoagulation) allowed Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Germany | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01228799 | ||||||||
| Other Study ID Numbers ICMJE | TVC-1, TVC | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | University Eye Hospital, University Hospitals Würzburg | ||||||||
| Study Sponsor ICMJE | University Eye Hospital, Würzburg | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | University Eye Hospital, Würzburg | ||||||||
| Verification Date | October 2010 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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