Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
70 participants
OBSERVATIONAL
1995-07-31
2006-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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 Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* 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
45 Years
86 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Shinjo Ophthalmologic Institute
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Shinjo Ophthalmologic Institute
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kazuyuki Kumagai, MD
Role: PRINCIPAL_INVESTIGATOR
Shinjo Ophthalmologic Institute
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Shinjo Ophthalmologic Institute
Miyazaki, Miyazaki, Japan
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Kumagai BRVO
Identifier Type: -
Identifier Source: secondary_id
KK-R-207-430R1
Identifier Type: -
Identifier Source: org_study_id