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Sheathotomy vs. Intravitreal Triamcinolone for Branch Retinal Vein Occlusion
This study has been completed.
Study NCT00612261   Information provided by Yonsei University
First Received: January 25, 2008   No Changes Posted

January 25, 2008
January 25, 2008
October 2006
August 2007   (final data collection date for primary outcome measure)
best-corrected ETDRS visual acuity score [ Time Frame: baseline, at 1,3,6 months after either treatment ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
complication rate [ Time Frame: at 1,3,6 months after either treatment ] [ Designated as safety issue: Yes ]
Same as current
 
Sheathotomy vs. Intravitreal Triamcinolone for Branch Retinal Vein Occlusion
Arteriovenous Crossing Sheathotomy Versus Intravitreal Triamcinolone Acetonide Injection for Treatment of Macular Edema Associated With Branch Retinal Vein Occlusion

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).

 
 
Interventional
Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Safety Study
  • Macular Edema
  • Branch Retinal Vein Occlusion
  • Procedure: Arteriovenous Crossing Sheathotomy
  • Procedure: Intravitreal Triamcinolone Acetonide Injection
  • Experimental: The group 1 patients receive AV sheathotomy for macular edema secondary to branch retinal vein occlusion.
  • Active Comparator: The group 2 patients receive IVTA.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
40
August 2007
August 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • recent onset (within the 6 months prior to enrollment) of macular edema resulting from BRVO
  • best corrected Early Treatment Diabetic Retinopathy Study (ETDRS) scores ≤ 40 letters (Snellen equivalent ≤ 20/40
  • intraretinal hemorrhages involving the foveal centers
  • generalized breakdown of the inner blood-retina barrier, as documented by diffuse fluorescein leakage on angiography, or diffuse thickening of the retina on optical coherence tomography (OCT), with involvement of the foveal center and most of the macular area, and with foveal thicknesses ≥ 250 micrometer

Exclusion Criteria:

  • prior history of intraocular surgery including cataract extraction
  • prior history of laser treatments including panretinal photocoagulation and focal/grid macular photocoagulation
  • prior history of elevated intraocular pressure secondary to steroid treatment
  • prior history of glaucoma or ocular hypertension
  • presence of comorbid ocular conditions that might affect visual acuity (VA).
Both
 
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00612261
Hyoung Jun Koh, Yonsei University
koh003
Yonsei University
 
Principal Investigator: Hyoung Jun Koh, MD, PhD Yonsei University Heath System
Yonsei University
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP