Vitrectomy for Branch Retinal Vein Occlusion

Vitrectomy Clinical Trial

Official title:

Vitrectomy for Persistent Macular Edema in Branch Retinal Vein Occlusion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00685490
• Other study ID #: KK-R-207-430R1
• Secondary ID: Kumagai BRVO
• Status: Completed
• Phase: N/A
• First received: May 22, 2008
• Last updated: May 23, 2008
• Start date: July 1995
• Est. completion date: November 2006

Study information

• Verified date: May 2008
• Source: Shinjo Ophthalmologic Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

To evaluate the long term outcomes of pars plana vitrectomy (PPV), with and without internal limiting membrane (ILM) peeling, in eyes with persistent macular edema secondary to branch retinal vein occlusion (BRVO).

Results suggest the following hypothesis:

• PPV, with and without ILM peeling, appears to be beneficial in eyes with persistent macular edema due to BRVO

• Effectiveness is maintained long term

• ILM peeling does not significantly affect postoperative best corrected visual acuity (BCVA)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 86 Years

Eligibility

Inclusion Criteria:

• duration of symptoms lasting 27 weeks

Exclusion Criteria:

• vitreous hemorrhage

• severe cataract

• biomicroscopic vitreomacular traction and epiretinal membrane

• previous vitreoretinal surgery

• other ocular diseases that could contribute to visual loss.

• patients with macular branch vein occlusion

• patients with a history of previous grid laser photocoagulation

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Retinal Vein Occlusion
• Vitrectomy

Intervention

Procedure:
• Vitrectomy w/o ILM peeling for macular edema with BRVO
Concurrent phacoemulsification and intraocular lens insertion in the capsular bag was performed, followed by PPV with separation of the posterior hyaloid from the optic disk and posterior retina with a posterior vitreous detachment was not present. Indocyanine green (ICG)-assisted peeling was performed in all consecutive patients between April 2000 and June 2003. 0.1% ICG solution was injected over the macular region. Immediately after application, the dye was washed out using a vitreous cutter. Repeated injection of ICG was not required. Triamcinolone acetonide (TA)-assisted ILM peeling was performed in all consecutive patients from July 2003 to November 2006.

Locations

Country	Name	City	State
Japan	Shinjo Ophthalmologic Institute	Miyazaki

Sponsors (1)

Lead Sponsor	Collaborator
Shinjo Ophthalmologic Institute

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reporting of the long term outcomes of PPV, with and without ILM peeling, in eyes with persistent macular edema secondary to BRVO		11 years	No
Secondary	Elevate the effectiveness of ILM peeling		11 years	No