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Sheathotomy vs. Intravitreal Triamcinolone for Branch Retinal Vein Occlusion

Primary Purpose

Macular Edema, Branch Retinal Vein Occlusion

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Arteriovenous Crossing Sheathotomy
Intravitreal Triamcinolone Acetonide Injection
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Edema focused on measuring Branch retinal vein occlusion; treatment

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Yonsei University Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

The group 1 patients receive AV sheathotomy for macular edema secondary to branch retinal vein occlusion.

The group 2 patients receive IVTA.

Outcomes

Primary Outcome Measures

best-corrected ETDRS visual acuity score

Secondary Outcome Measures

complication rate

Full Information

First Posted
January 25, 2008
Last Updated
January 25, 2008
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT00612261
Brief Title
Sheathotomy vs. Intravitreal Triamcinolone for Branch Retinal Vein Occlusion
Official Title
Arteriovenous Crossing Sheathotomy Versus Intravitreal Triamcinolone Acetonide Injection for Treatment of Macular Edema Associated With Branch Retinal Vein Occlusion
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Edema, Branch Retinal Vein Occlusion
Keywords
Branch retinal vein occlusion; treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
The group 1 patients receive AV sheathotomy for macular edema secondary to branch retinal vein occlusion.
Arm Title
2
Arm Type
Active Comparator
Arm Description
The group 2 patients receive IVTA.
Intervention Type
Procedure
Intervention Name(s)
Arteriovenous Crossing Sheathotomy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Intravitreal Triamcinolone Acetonide Injection
Intervention Description
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.
Primary Outcome Measure Information:
Title
best-corrected ETDRS visual acuity score
Time Frame
baseline, at 1,3,6 months after either treatment
Secondary Outcome Measure Information:
Title
complication rate
Time Frame
at 1,3,6 months after either treatment

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyoung Jun Koh, MD, PhD
Organizational Affiliation
Yonsei University Heath System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yonsei University Health System
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
16996596
Citation
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. doi: 10.1016/j.ophtha.2006.05.056. Epub 2006 Sep 25.
Results Reference
background
PubMed Identifier
16527226
Citation
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. doi: 10.1016/j.ajo.2005.12.011. Epub 2006 Mar 9.
Results Reference
background
PubMed Identifier
16077348
Citation
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. doi: 10.1097/00006982-200507000-00001.
Results Reference
background
PubMed Identifier
15953467
Citation
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. doi: 10.1016/j.ajo.2005.02.024. No abstract available.
Results Reference
background
PubMed Identifier
15953425
Citation
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. doi: 10.1016/j.ajo.2004.12.087.
Results Reference
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PubMed Identifier
15808186
Citation
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. doi: 10.1016/j.ajo.2004.10.026.
Results Reference
background
PubMed Identifier
15805902
Citation
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. doi: 10.1097/00006982-200504000-00004.
Results Reference
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PubMed Identifier
15751246
Citation
Ozkiris A, Evereklioglu C, Erkilic 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. doi: 10.1177/112067210501500115.
Results Reference
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PubMed Identifier
15723039
Citation
Ozkiris A, Evereklioglu C, Erkilic K, Dogan H. Intravitreal triamcinolone acetonide for treatment of persistent macular oedema in branch retinal vein occlusion. Eye (Lond). 2006 Jan;20(1):13-7. doi: 10.1038/sj.eye.6701803.
Results Reference
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PubMed Identifier
15629280
Citation
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. doi: 10.1016/j.ajo.2004.06.061.
Results Reference
background
PubMed Identifier
15300073
Citation
Garcia-Arumi 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. doi: 10.1097/00006982-200408000-00005.
Results Reference
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Sheathotomy vs. Intravitreal Triamcinolone for Branch Retinal Vein Occlusion

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