Vitrectomy for Branch Retinal Vein Occlusion - Tabular View

Tracking Information

First Received Date ^ICMJE

May 22, 2008

Last Updated Date

May 23, 2008

Start Date ^ICMJE

July 1995

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00685490 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Vitrectomy for Branch Retinal Vein Occlusion

Official Title ^ICMJE

Vitrectomy for Persistent Macular Edema in Branch Retinal Vein Occlusion

Brief 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)

Detailed Description

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Case-Only, Retrospective

Condition ^ICMJE

Vitrectomy

Intervention ^ICMJE

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

Study Arms / Comparison Groups

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

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

45 Years to 86 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT ID ^ICMJE

NCT00685490

Responsible Party

Kazuyuki Kumagai, Shinjo Ophthalmologic Institute

Study ID Numbers ^ICMJE

KK-R-207-430R1, Kumagai BRVO

Study Sponsor ^ICMJE

Shinjo Ophthalmologic Institute

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Kazuyuki Kumagai, MD

Shinjo Ophthalmologic Institute

Information Provided By

Shinjo Ophthalmologic Institute

Verification Date

May 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP