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| Tracking Information | |||||
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| First Received Date ICMJE | November 2, 2006 | ||||
| Last Updated Date | June 28, 2009 | ||||
| Start Date ICMJE | August 2006 | ||||
| Primary Completion Date | |||||
| 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 NCT00403702 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Comparison High-Density Silicone Oils in Retinal Detachment | ||||
| Official Title ICMJE | Comparison of Two High-Density Silicone Oils in Complicated Rhegmatogenous Retinal Detachment | ||||
| Brief Summary | The purpose of the study is to compare the safety, intraocular adverse effects and the anatomic and functional outcome with two endotamponade silicone oil after a 3-month in complex inferior retinal re-detachments. |
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| Detailed Description | Five to 10% of retinal detachments progressed to proliferative vitreoretinopathy (PVR), the common more cause of surgical failure of retina detachment. Despite the use of internal tamponades, the treatment of retinal detachments due to a progressed proliferative vitreoretinopathy (PVR) is still a problem. At present, conventional silicone oil, having a lower specific gravity than water, is an excellent tool in advanced PVR retinal detachment especially of the upper circumference. In the past, to diminish the re-detachments diverse heavier-than-water density endotamponades were investigated by to use in in cases of inferior PVR. However,heavier-than-water density endotamponades have demonstrated adverse short term effects. (Example: silicon dispersion: hypotension and inflammation) Recently, two new long-term heavier-than-water internal tamponades were introduced: Oxane HD [oil-RMN3-mixture] and Densiron [mixture of 30.5 vol% perfluorohexyloctane (F6H8) with 69.5 vol% polydimethylsiloxane (silicone oil)], showing satisfying anatomical results and good intraocular tolerance. In the present study, we will compare the anatomical outcome, functional results and intraocular adverse effects of two types of heavier tamponades. |
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| Study Phase | Phase II, Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double-Blind, Historical Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Retinal Detachment | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 10 | ||||
| Estimated Completion Date | August 2007 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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 | Mexico | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00403702 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | APEC-0021 | ||||
| Study Sponsor ICMJE | Asociación para Evitar la Ceguera en México | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Asociación para Evitar la Ceguera en México | ||||
| Verification Date | November 2006 | ||||
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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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