Branch Retinal Vein OcclusionNCT02215109
Retinal Vessel Diameter in Branch Retinal Vein Occlusion
An observational study of Branch Retinal Vein Occlusion, run by Kyungpook National University Hospital at 1 site in South Korea.
Trial summary
The authors investigated the consecutive change of retinal vessel's diameter in affected eye and fellow eye of Branch Retinal Vein Occlusion. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Branch Retinal Vein Occlusion
- Type of treatment
- Injection or infusion
- How many people
- 25 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2012to Aug 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 25 patients will be included. All subjects with branch retinal vein occlusion scheduled for intravitreal bevacizumab injection.
Who may be able to join
- Best-corrected visual acuity less than 20/40
- Central subfield macular thickness (CSMT) 300 μm or greater on spectral-domain optical coherence tomography
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Branch Retinal Vein Occlusion
- Medical subject headings
- Retinal Vein Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| BRVO, Retinal vessel diameter | The retinal vessel diameter was measured Branch Retinal Vein Occlusion patients after intravitreal bevacizumab injection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0, 1, 3, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2014 (estimated)
- Study startApr 2012
- Primary completionJul 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Branch Retinal Vein OcclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyungpook National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong Ho Park, Kyungpook National University Hospital
- Investigators
- Dong Ho Park, M.D., Principal investigator, Kyungpook National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02215109
- Sponsor's protocol ID
- KNUHOPH2014-01
- Status last verified
- Aug 2016
- First submitted
- 11 Aug 2014
- Last updated
- 30 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Change of Retinal Vessel Diameter in Branch Retinal Vein Occlusion After Intravitreal Bevacizumab Injection
- ClinicalTrials.gov ID
- NCT02215109
- Acronym / sponsor ID
- KNUHOPH2014-01
- Conditions
- Branch Retinal Vein Occlusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Kyungpook National University HospitalUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Jul 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 13 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BRVO, Retinal vessel diameter | – | –The retinal vessel diameter was measured Branch Retinal Vein Occlusion patients after intravitreal bevacizumab injection. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 25 patients will be included. All subjects with branch retinal vein occlusion scheduled for intravitreal bevacizumab injection.
Key inclusion criteria (2 listed)
- Best-corrected visual acuity less than 20/40
- Central subfield macular thickness (CSMT) 300 μm or greater on spectral-domain optical coherence tomography
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2016.
- Individual participant dataSharing planned: No
Related trials for Branch Retinal Vein Occlusion
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Active, not recruitingObservational study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dong Ho Park, M.D. principal investigator
Kyungpook National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Branch Retinal Vein Occlusion, run by Kyungpook National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unoccluded retinal vessel diameter of Branch Retinal Vein Occlusion (time frame: 0, 1, 3, and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2016.