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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02215109
Other study ID # KNUHOPH2014-01
Secondary ID
Status Completed
Phase N/A
First received August 11, 2014
Last updated August 29, 2016
Start date April 2012
Est. completion date August 2016

Study information

Verified date August 2016
Source Kyungpook National University
Contact n/a
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date August 2016
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender Both
Age group 40 Years to 85 Years
Eligibility 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 Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Korea, Republic of Dong Ho Park Daegu Kyungsangpookdo

Sponsors (1)

Lead Sponsor Collaborator
Kyungpook National University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Unoccluded retinal vessel diameter of Branch Retinal Vein Occlusion To evaluate the change of unoccluded retinal vessel diameter in affected eye of Branch Retinal Vein Occlusion and unaffected fellow eye. 0, 1, 3, and 6 months No
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