Sheathotomy vs. Intravitreal Triamcinolone for Branch Retinal Vein Occlusion
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|ClinicalTrials.gov Identifier: NCT00612261|
Recruitment Status : Completed
First Posted : February 11, 2008
Last Update Posted : February 11, 2008
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).
|Condition or disease||Intervention/treatment||Phase|
|Macular Edema Branch Retinal Vein Occlusion||Procedure: Arteriovenous Crossing Sheathotomy Procedure: Intravitreal Triamcinolone Acetonide Injection||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Arteriovenous Crossing Sheathotomy Versus Intravitreal Triamcinolone Acetonide Injection for Treatment of Macular Edema Associated With Branch Retinal Vein Occlusion|
|Study Start Date :||October 2006|
|Actual Primary Completion Date :||August 2007|
|Actual Study Completion Date :||August 2007|
The group 1 patients receive AV sheathotomy for macular edema secondary to branch retinal vein occlusion.
Procedure: Arteriovenous Crossing Sheathotomy
In each sheathotomy patient, a standard pars plana vitrectomy is performed, followed by surgical separation of the posterior cortical vitreous from the optic nerve and posterior retina. After the relevant arteriovenous crossing site is identified based on preoperative FA, a bent microvitreoretinal blade is used to open the internal limiting membrane and the nerve fiber layer over the artery, with the incision commencing 100-200 micrometer proximal to the AV crossing. The incision is continued parallel to and under the retinal arteriole, with a gentle lifting motion, until the common AV crossing sheath is encountered and incised in a side-to-side manner. The completion of AV dissection is confirmed by an elevation of the overlying artery.
Active Comparator: 2
The group 2 patients receive IVTA.
Procedure: Intravitreal Triamcinolone Acetonide Injection
The IVTA group receive intravitreal injection of 4 mg/0.1 mL triamcinolone acetonide (40 mg/mL; Tamceton®; Hanall Pharmaceutical, Seoul, Korea). The injections are performed using 0.5% proparacaine drops (Alcaine®; Alcon Laboratories, Fort Worth, TX) for topical anesthesia under sterile conditions. The drug is injected through the inferotemporal pars plana using a 30-gauge needle. The correct intravitreal localization of the suspension, and perfusion of the optic nerve head, are then confirmed by indirect ophthalmoscopy.
- best-corrected ETDRS visual acuity score [ Time Frame: baseline, at 1,3,6 months after either treatment ]
- complication rate [ Time Frame: at 1,3,6 months after either treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00612261
|Korea, Republic of|
|Yonsei University Health System|
|Seoul, Korea, Republic of, 120-752|
|Principal Investigator:||Hyoung Jun Koh, MD, PhD||Yonsei University Heath System|