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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | January 25, 2008 | ||||
| Last Updated Date | January 25, 2008 | ||||
| Start Date ICMJE | October 2006 | ||||
| Primary Completion Date | August 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
best-corrected ETDRS visual acuity score [ Time Frame: baseline, at 1,3,6 months after either treatment ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
complication rate [ Time Frame: at 1,3,6 months after either treatment ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Sheathotomy vs. Intravitreal Triamcinolone for Branch Retinal Vein Occlusion | ||||
| Official Title ICMJE | Arteriovenous Crossing Sheathotomy Versus Intravitreal Triamcinolone Acetonide Injection for Treatment of Macular Edema Associated With Branch Retinal Vein Occlusion | ||||
| Brief Summary | Branch retinal vein occlusion (BRVO) is a common retinal vascular disease occurring in a significant number of individuals older than 50 years.The most common cause of visual disturbance in BRVO patients is macular edema, which has been reported in 60% of patients. Macular grid laser photocoagulation has been shown to be effective in the treatment of macular edema arising from BRVO. Some eyes are resistant to conventional grid laser treatment, and the conventional treatment is not useful in patients with intraretinal hemorrhages that may interfere with laser photocoagulation. Moreover, several studies have shown that conventional grid laser treatment for macular edema may be associated with complications. Intravitreal triamcinolone acetonide (IVTA) injection has recently been reported to be effective in the treatment of macular edema of various etiologies.On the other hand, arteriovenous sheathotomy is a surgical method suggested for treatment of macular edema in BRVO patients, and has been reported to be efficacious in patients refractory to conventional focal or grid laser macular photocoagulation.Both treatment modalities have been reported to be associated with reductions in central macular thicknesses and improved visual acuities. The purpose of the study is to compare the efficacies of arteriovenous (AV) sheathotomy and intravitreal triamcinolone (IVTA) injection in the treatment of macular edema associated with branch retinal vein occlusion (BRVO). |
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| Detailed Description | |||||
| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Safety Study | ||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| 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 | 40 | ||||
| Completion Date | August 2007 | ||||
| Primary Completion Date | August 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | |||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Korea, Republic of | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00612261 | ||||
| Responsible Party | Hyoung Jun Koh, Yonsei University | ||||
| Study ID Numbers ICMJE | koh003 | ||||
| Study Sponsor ICMJE | Yonsei University | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Yonsei University | ||||
| Verification Date | January 2008 | ||||
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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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