Vitrectomy for Branch Retinal Vein Occlusion

This study has been completed.
Sponsor:
Information provided by:
Shinjo Ophthalmologic Institute
ClinicalTrials.gov Identifier:
NCT00685490
First received: May 22, 2008
Last updated: May 23, 2008
Last verified: May 2008
  Purpose

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)

Condition Intervention
Vitrectomy
Procedure: Vitrectomy w/o ILM peeling for macular edema with BRVO

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Vitrectomy for Persistent Macular Edema in Branch Retinal Vein Occlusion

Resource links provided by NLM:


Further study details as provided by Shinjo Ophthalmologic Institute:

Primary Outcome Measures:
  • Reporting of the long term outcomes of PPV, with and without ILM peeling, in eyes with persistent macular edema secondary to BRVO [ Time Frame: 11 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Elevate the effectiveness of ILM peeling [ Time Frame: 11 years ] [ Designated as safety issue: No ]

Enrollment: 70
Study Start Date: July 1995
Study Completion Date: November 2006
Groups/Cohorts Assigned Interventions
Surgical
Retrospective chart review of 70 eyes of 70 consecutive patients who underwent PPV, with and without ILM peeling, for persistent macular edema associated with BRVO
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.

  Eligibility

Ages Eligible for Study:   45 Years to 86 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

70 consecutive patients who underwent PPV, with and without OLM peeling, for persistent macular edema associted with BRVO

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00685490

Locations
Japan
Shinjo Ophthalmologic Institute
Miyazaki, Japan, 880-0035
Sponsors and Collaborators
Shinjo Ophthalmologic Institute
Investigators
Principal Investigator: Kazuyuki Kumagai, MD Shinjo Ophthalmologic Institute
  More Information

No publications provided

Responsible Party: Kazuyuki Kumagai, Shinjo Ophthalmologic Institute
ClinicalTrials.gov Identifier: NCT00685490     History of Changes
Other Study ID Numbers: KK-R-207-430R1, Kumagai BRVO
Study First Received: May 22, 2008
Last Updated: May 23, 2008
Health Authority: Japan: Institutional Review Board

Keywords provided by Shinjo Ophthalmologic Institute:
branch retinal vein occlusion
internal limiting membrane
macular edema
vitrectomy

Additional relevant MeSH terms:
Macular Edema
Retinal Vein Occlusion
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014