NCT02215109

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

August 11, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 13, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

August 30, 2016

Status Verified

August 1, 2016

Enrollment Period

4.3 years

First QC Date

August 11, 2014

Last Update Submit

August 29, 2016

Conditions

Branch Retinal Vein Occlusion

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

BRVO, Retinal vessel diameter

The retinal vessel diameter was measured Branch Retinal Vein Occlusion patients after intravitreal bevacizumab injection.

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A total of 25 patients will be included. All subjects with branch retinal vein occlusion scheduled for intravitreal bevacizumab injection.

You may qualify if:

  • Best-corrected visual acuity less than 20/40
  • Central subfield macular thickness (CSMT) 300 μm or greater on spectral-domain optical coherence tomography

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dong Ho Park

Daegu, Kyungsangpookdo, 700-721, South Korea

Location

MeSH Terms

Conditions

Retinal Vein Occlusion

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesVenous ThrombosisThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Dong Ho Park, M.D.

    Kyungpook National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical professor

Study Record Dates

First Submitted

August 11, 2014

First Posted

August 13, 2014

Study Start

April 1, 2012

Primary Completion

July 1, 2016

Study Completion

August 1, 2016

Last Updated

August 30, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)