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Retinal Vessel Diameter in Branch Retinal Vein Occlusion

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ClinicalTrials.gov Identifier: NCT02215109
Recruitment Status : Completed
First Posted : August 13, 2014
Last Update Posted : August 30, 2016
Sponsor:
Information provided by (Responsible Party):
Dong Ho Park, Kyungpook National University Hospital

Brief Summary:
The authors investigated the consecutive change of retinal vessel's diameter in affected eye and fellow eye of Branch Retinal Vein Occlusion.

Condition or disease
Branch Retinal Vein Occlusion

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.

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Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Change of Retinal Vessel Diameter in Branch Retinal Vein Occlusion After Intravitreal Bevacizumab Injection
Study Start Date : April 2012
Actual Primary Completion Date : July 2016
Actual Study Completion Date : August 2016

Group/Cohort
BRVO, Retinal vessel diameter
The retinal vessel diameter was measured Branch Retinal Vein Occlusion patients after intravitreal bevacizumab injection.



Primary Outcome Measures :
  1. Unoccluded retinal vessel diameter of Branch Retinal Vein Occlusion [ Time Frame: 0, 1, 3, and 6 months ]
    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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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02215109


Locations
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Korea, Republic of
Dong Ho Park
Daegu, Kyungsangpookdo, Korea, Republic of, 700-721
Sponsors and Collaborators
Kyungpook National University Hospital
Investigators
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Principal Investigator: Dong Ho Park, M.D. Kyungpook National University Hospital

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Responsible Party: Dong Ho Park, Clinical professor, Kyungpook National University Hospital
ClinicalTrials.gov Identifier: NCT02215109    
Other Study ID Numbers: KNUHOPH2014-01
First Posted: August 13, 2014    Key Record Dates
Last Update Posted: August 30, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Retinal Vein Occlusion
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors