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OpenTrials
Completed

NCT Number: NCT00685490

Vitrectomy for Branch Retinal Vein Occlusion

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)

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Key information

Age range

45 year–86 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shinjo Ophthalmologic Institute

Miyazaki, 880-0035, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitrectomy w/o ILM peeling for macular edema with BRVO

Procedure

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Elevate the effectiveness of ILM peeling

    Time frame: 11 years

Sponsors and collaborators

Lead sponsor

Shinjo Ophthalmologic Institute

Other

Registry information

Official study title

Vitrectomy for Persistent Macular Edema in Branch Retinal Vein Occlusion

Important dates

Study start
1995
Study completion
2006
First posted
May 28, 2008
Registry last updated
May 28, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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