Pressurized PPV 23GA Vitrectomy in Complicated Diabetic Tractional Retinal Detachment
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2007 by Asociación para Evitar la Ceguera en México.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Asociación para Evitar la Ceguera en México
Information provided by:
Asociación para Evitar la Ceguera en México
ClinicalTrials.gov Identifier:
NCT00404209
First received: June 30, 2006
Last updated: November 29, 2007
Last verified: November 2007
| Tracking Information | |||||||||
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| First Received Date ICMJE | June 30, 2006 | ||||||||
| Last Updated Date | November 29, 2007 | ||||||||
| Start Date ICMJE | March 2007 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE |
Perfluorocarbon liquids consumption [ Time Frame: two months ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT00404209 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Pressurized PPV 23GA Vitrectomy in Complicated Diabetic Tractional Retinal Detachment | ||||||||
| Official Title ICMJE | Pressurized Perfluorocarbon Perfused 23 GA Vitrectomy in Complicated Diabetic Retinal Detachment | ||||||||
| Brief Summary | To investigate the feasibility and advantages of using pressurized perfluorocarbon liquid (PCL) perfusion to remove vitreous during suction-cutting 23 GA vitrectomy using a dual, dynamic drive (3D)technology, in complicated retinal detachment surgeries. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 3 | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Retinal Detachment | ||||||||
| Intervention ICMJE | Procedure: Vitrectomy
pressurized 23GA vitrectomy with a 3D system |
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| Study Arm (s) | Not Provided | ||||||||
| 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 | 10 | ||||||||
| Estimated Completion Date | February 2008 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | Not Provided | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Mexico | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00404209 | ||||||||
| Other Study ID Numbers ICMJE | APEC-008 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | Hugo Quiroz-Mercado, Asociacion para evitar la ceguera en Mexico | ||||||||
| Study Sponsor ICMJE | Asociación para Evitar la Ceguera en México | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Asociación para Evitar la Ceguera en México | ||||||||
| Verification Date | November 2007 | ||||||||
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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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