- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02215109
Retinal Vessel Diameter in Branch Retinal Vein Occlusion
August 29, 2016 updated by: Dong Ho Park, Kyungpook National University Hospital
Change of Retinal Vessel Diameter in Branch Retinal Vein Occlusion After Intravitreal Bevacizumab Injection
The authors investigated the consecutive change of retinal vessel's diameter in affected eye and fellow eye of Branch Retinal Vein Occlusion.
Study Overview
Status
Completed
Conditions
Detailed Description
Twenty five consecutive patients who had undergone intravitreal bevacizumab injection for Branch Retinal Vein Occlusion with macular edema were included in this study.
All subjects were enrolled between April, 2012 and April, 2013 in the Department of Ophthalmology, Kyungpook National University Hospital.
Study Type
Observational
Enrollment (Actual)
25
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kyungsangpookdo
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Daegu, Kyungsangpookdo, Korea, Republic of, 700-721
- Dong Ho Park
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
A total of 25 patients will be included.
All subjects with branch retinal vein occlusion scheduled for intravitreal bevacizumab injection.
Description
Inclusion Criteria:
- Best-corrected visual acuity less than 20/40
- Central subfield macular thickness (CSMT) 300 μm or greater on spectral-domain optical coherence tomography
Exclusion Criteria:
- Patients with recurrent BRVO
- History of previous treatments for BRVO including vitreoretinal surgery, intravitreal injection, subtenon injection or laser photocoagulation
- Patients with diabetes or dyslipidemia
- IOP ≥ 22mmHg, treatment for glaucoma, a family history of glaucoma, or optic neuropathy
- High myopia (<-6 Diopters), high hyperopia (>6 Diopters) or a history of refractive surgeries
- Co-existing retinal disease other than BRVO
- Corneal diseases include ulcer, keratoconus and a history of corneal laceration
- Cataract and other media opacities resulting in visual impairment or poor fundus images
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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BRVO, Retinal vessel diameter
The retinal vessel diameter was measured Branch Retinal Vein Occlusion patients after intravitreal bevacizumab injection.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Unoccluded retinal vessel diameter of Branch Retinal Vein Occlusion
Time Frame: 0, 1, 3, and 6 months
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To evaluate the change of unoccluded retinal vessel diameter in affected eye of Branch Retinal Vein Occlusion and unaffected fellow eye.
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0, 1, 3, and 6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2012
Primary Completion (Actual)
July 1, 2016
Study Completion (Actual)
August 1, 2016
Study Registration Dates
First Submitted
August 11, 2014
First Submitted That Met QC Criteria
August 12, 2014
First Posted (Estimate)
August 13, 2014
Study Record Updates
Last Update Posted (Estimate)
August 30, 2016
Last Update Submitted That Met QC Criteria
August 29, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KNUHOPH2014-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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