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| Tracking Information | |||||||||||||||||
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| First Received Date ICMJE | June 11, 2007 | ||||||||||||||||
| Last Updated Date | June 11, 2007 | ||||||||||||||||
| Start Date ICMJE | January 2005 | ||||||||||||||||
| Primary Completion Date | |||||||||||||||||
| Current Primary Outcome Measures ICMJE |
BCVA improvement,anatomic success [ Time Frame: 1,3,6,9, and 12 months after treatment ] | ||||||||||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||
| Change History | No Changes Posted | ||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||
| Descriptive Information | |||||||||||||||||
| Brief Title ICMJE | Pneumatic Retinopexy Versus Vitrectomy With Gas for Retinal Detachment Due to Myopic Macular Hole | ||||||||||||||||
| Official Title ICMJE | Pneumatic Retinopexy Versus Vitrectomy With Gas for Retinal Detachment Due to Myopic Macular Hole | ||||||||||||||||
| Brief Summary | To undertake a prospective randomized clinical study for treating retinal detachment due to myopic macular holes, utilizing pneumatic retinopexy versus pars plana vitrectomy with gas tamponade.To determine the efficiency of pneumatic retinopexy with C3F8 in the treatment of retinal detachment due to myopic macular hole. |
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| Detailed Description | Retinal detachment caused by macular hole predominantly happened in high myopic eyes. This is a common type of retinal detachment in Asia and often seen in the old people aged around 50 ~ 60, mainly in female. Treatment of retinal detachment due to macular holes has changed over the years, and several methods have been described. Some surgeons have used transscleral diathermy or cryotherapy or laser photocoagulation and drainage subretinal fluid without sclera buckling, other surgeons have used radial silicone explants beneath the macular combined with cryo, diathermy or laser. This method entails the difficulty of placing sclera sutures far posterior, especially hazardous if there is a posterior staphyloma with very thin sclera. Besides the technically difficult, the extensive macular scarring caused by different coagulations limited the functional result to peripheral vision only. Because of this, it is not generally used in the initial treatment. In 1982, Gonvers and Machemer4 proposed a new treatment technique that combined pars plana vitrectomy (PPV), partial air–fluid exchange, and face down positioning for 24 hours. Since then vitrectomy with gas tamponade become the most common procedure for retinal detachment with macular hole. In 1984, Miyake performed a simple gas injection into the vitreous followed by a face-down position. The effective of this simplified method was then reported by many observers.But these studies may have insufficiency because of small sample, nonrandomized, no defined eligibility criteria for patients selection. Intraocular gas tamponade with or without pars plana vitrectomy (PPV) has commonly been performed nowadays. We conducted a multicenter randomized controlled clinical trial to compare their anatomic results and visual outcomes of both surgical techniques, to estimate the efficiency of both surgical methods in the treatment of retinal detachment with myopic macular hole. |
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| Study Phase | |||||||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||||||
| Study Design ICMJE | Treatment, Randomized, Single Blind, Active 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 | Completed | ||||||||||||||||
| Enrollment ICMJE | 231 | ||||||||||||||||
| Completion Date | December 2006 | ||||||||||||||||
| Primary Completion Date | |||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||||||
| Ages | 18 Years to 90 Years | ||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||
| Location Countries ICMJE | China | ||||||||||||||||
| Administrative Information | |||||||||||||||||
| NCT ID ICMJE | NCT00485199 | ||||||||||||||||
| Responsible Party | |||||||||||||||||
| Study ID Numbers ICMJE | RDMH2007-china | ||||||||||||||||
| Study Sponsor ICMJE | Peking University | ||||||||||||||||
| Collaborators ICMJE | |||||||||||||||||
| Investigators ICMJE |
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| Information Provided By | Peking University | ||||||||||||||||
| Verification Date | June 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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