Sheathotomy vs. Intravitreal Triamcinolone for Branch Retinal Vein Occlusion

Condition(s) targeted: Macular Edema; Branch Retinal Vein Occlusion

Intervention: Arteriovenous Crossing Sheathotomy (Procedure); Intravitreal Triamcinolone Acetonide Injection (Procedure)

Phase: N/A

Status: Completed

Sponsored by: Yonsei University

Official(s) and/or principal investigator(s):
Hyoung Jun Koh, MD, PhD, Principal Investigator, Affiliation: Yonsei University Heath System

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).

Official title: Arteriovenous Crossing Sheathotomy Versus Intravitreal Triamcinolone Acetonide Injection for Treatment of Macular Edema Associated With Branch Retinal Vein Occlusion

Study design: Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Safety Study

Primary outcome: best-corrected ETDRS visual acuity score

Secondary outcome: complication rate

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

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).

Yonsei University Health System, Seoul 120-752, Korea, Republic of

Related publications:

Parodi MB, Spasse S, Iacono P, Di Stefano G, Canziani T, Ravalico G. Subthreshold grid laser treatment of macular edema secondary to branch retinal vein occlusion with micropulse infrared (810 nanometer) diode laser. Ophthalmology. 2006 Dec;113(12):2237-42. Epub 2006 Sep 25.

Chen SD, Sundaram V, Lochhead J, Patel CK. Intravitreal triamcinolone for the treatment of ischemic macular edema associated with branch retinal vein occlusion. Am J Ophthalmol. 2006 May;141(5):876-883. Epub 2006 Mar 9.

Lee H, Shah GK. Intravitreal triamcinolone as primary treatment of cystoid macular edema secondary to branch retinal vein occlusion. Retina. 2005 Jul-Aug;25(5):551-5.

Chalam KV, Shah GY, Shah VA. Vitrectomy with or without arteriovenous adventitial sheathotomy for macular edema associated with branch retinal vein occlusion. Am J Ophthalmol. 2005 Jun;139(6):1146; author reply 1146-7. No abstract available.

Hayashi K, Hayashi H. Intravitreal versus retrobulbar injections of triamcinolone for macular edema associated with branch retinal vein occlusion. Am J Ophthalmol. 2005 Jun;139(6):972-82.

Horio N, Horiguchi M. Effect of arteriovenous sheathotomy on retinal blood flow and macular edema in patients with branch retinal vein occlusion. Am J Ophthalmol. 2005 Apr;139(4):739-40.

Lakhanpal RR, Javaheri M, Ruiz-Garcia H, De Juan E Jr, Humayun MS. Transvitreal limited arteriovenous-crossing manipulation without vitrectomy for complicated branch retinal vein occlusion using 25-gauge instrumentation. Retina. 2005 Apr-May;25(3):272-80.

Ozkiris A, Evereklioglu C, Erkiliç K, Ilhan O. The efficacy of intravitreal triamcinolone acetonide on macular edema in branch retinal vein occlusion. Eur J Ophthalmol. 2005 Jan-Feb;15(1):96-101.

Ozkiris A, Evereklioglu C, Erkilic K, Dogan H. Intravitreal triamcinolone acetonide for treatment of persistent macular oedema in branch retinal vein occlusion. Eye. 2006 Jan;20(1):13-7.

Yamamoto S, Saito W, Yagi F, Takeuchi S, Sato E, Mizunoya S. Vitrectomy with or without arteriovenous adventitial sheathotomy for macular edema associated with branch retinal vein occlusion. Am J Ophthalmol. 2004 Dec;138(6):907-14.

García-Arumí J, Martinez-Castillo V, Boixadera A, Blasco H, Corcostegui B. Management of macular edema in branch retinal vein occlusion with sheathotomy and recombinant tissue plasminogen activator. Retina. 2004 Aug;24(4):530-40.

Starting date: October 2006
Ending date: August 2007
Last updated: January 25, 2008