Sheathotomy vs. Intravitreal Triamcinolone for Branch Retinal Vein Occlusion

This study has been completed.
Sponsor:
Information provided by:
Yonsei University
ClinicalTrials.gov Identifier:
NCT00612261
First received: January 25, 2008
Last updated: NA
Last verified: January 2008
History: No changes posted
  Purpose

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 Intervention
Macular Edema
Branch Retinal Vein Occlusion
Procedure: Arteriovenous Crossing Sheathotomy
Procedure: Intravitreal Triamcinolone Acetonide Injection

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Arteriovenous Crossing Sheathotomy Versus Intravitreal Triamcinolone Acetonide Injection for Treatment of Macular Edema Associated With Branch Retinal Vein Occlusion

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • best-corrected ETDRS visual acuity score [ Time Frame: baseline, at 1,3,6 months after either treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • complication rate [ Time Frame: at 1,3,6 months after either treatment ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: October 2006
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00612261

Locations
Korea, Republic of
Yonsei University Health System
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
Investigators
Principal Investigator: Hyoung Jun Koh, MD, PhD Yonsei University Heath System
  More Information

Publications:

Responsible Party: Hyoung Jun Koh, Yonsei University
ClinicalTrials.gov Identifier: NCT00612261     History of Changes
Other Study ID Numbers: koh003
Study First Received: January 25, 2008
Last Updated: January 25, 2008
Health Authority: Korea: Food and Drug Administration

Keywords provided by Yonsei University:
Branch retinal vein occlusion; treatment

Additional relevant MeSH terms:
Edema
Macular Edema
Retinal Vein Occlusion
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 24, 2014