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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00485199 |
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Date of registration:
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11/06/2007 |
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Primary sponsor: |
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Public title:
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Pneumatic Retinopexy Versus Vitrectomy With Gas for Retinal Detachment Due to Myopic Macular Hole
RDMH |
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Scientific title:
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Pneumatic Retinopexy Versus Vitrectomy With Gas for Retinal Detachment Due to Myopic Macular Hole |
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Date of first enrolment:
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January 2005 |
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Target sample size:
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231 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00485199 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
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Countries of recruitment
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China
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Contacts
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Name:
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Wenji Wang, professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of ophthalmology of Eye Ear Nose Throat Hospital, Fudan University, Shanghai |
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Name:
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Jialiang Zhao, professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Eye Institute of Peking Union Hospital, Peking Union Medical College |
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Name:
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Xiaoxin Li, professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Peking University |
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Name:
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Shibo Tang, professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Zhong Shan Ophthalmic Center, Sun Yat-sen University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- retinal detachment due to myopic macular hole.
- The ability to give informed consent and to return for follow-up visit for 12 months
Exclusion Criteria:
- retinal detachment with macular hole and peripheral hole/tear
- retinal detachment with severe proliferative vitreoretinopathy
- retinal detachment with choroidal detachment or rupture
- traction retinal detachment due to retinal vascular disease
- had vitrectomy in the past
- macular hole without retinal detachment
- foveal schiesis without retinal detachment
- secondary macular hole with retinal detachment
Age minimum:
18 Years
Age maximum:
90 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Retinal Detachment
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Intervention(s)
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Procedure: Pneumatic Retinopexy
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Procedure: Vitrectomy with Gas
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Primary Outcome(s)
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BCVA improvement,anatomic success
[Time Frame: 1,3,6,9, and 12 months after treatment]
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Secondary Outcome(s)
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complication
[Time Frame: 1,3,6,9, 12 months after treatment]
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costs of treatment
[Time Frame: right after the treatment]
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Secondary ID(s)
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RDMH2007-china
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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