Retinal Vessel Diameter in Branch Retinal Vein Occlusion | NCT02215109

Studies
Retinal Vessel Diameter in Branch Retinal Vein Occlusion

NCT02215109

Sponsor

Kyungpook National University Hospital

Status

Completed

Last Update Posted

Aug 30, 2016Estimated

Enrollment

25Actual

Phase

Not provided

Conditions

Branch Retinal Vein Occlusion

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2012

Primary Completion Date

Jul 2016Actual

Completion Date

Aug 2016Actual

First Submitted Date

Aug 11, 2014

First Submission Date that Met QC Criteria

Aug 12, 2014

First Posted Date

Aug 13, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 29, 2016

Last Update Posted Date

Aug 30, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dong Ho Park, Clinical professor, Kyungpook National University HospitalPrincipal Investigator

Lead Sponsor

Kyungpook National University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BRVO, Retinal vessel diameter		The retinal vessel diameter was measured Branch Retinal Vein Occlusion patients after intravitreal bevacizumab injection.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dong Ho Park, M.D.	Kyungpook National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dong Ho Park		Daegu	Kyungsangpookdo	700-721	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012170	Retinal Vein Occlusion

Ancestor Terms

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases
D020246	Venous Thrombosis
D013927	Thrombosis

Browse Leaves

Not provided

Browse Branches

Not provided