Central Retinal Vein OcclusionNCT00383773
Retinal Endo Vascular Surgery for Central Retinal Vein Occlusion
A study testing Retinal endo vascular surgery in people with Central Retinal Vein Occlusion, run by Hadassah Medical Organization.
Trial summary
Patients with Central Retinal Vein Occlusion will undergo vitrectomy, a small needle of about 71 micron will enter a branch retinal vein and TPA will be injected into the obstracted vein. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Central Retinal Vein Occlusion
- What is being tested?
- Retinal endo vascular surgery
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Oct 2006to Oct 2007
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- crvo less than 6 month
- Visual Acuity less than 6/21
- No prior eye surgery except cataract.
Who cannot join
- Retinal/iris neovascularization
Trial locations and contacts
No sites are listed yet.
About this study
Patients with Central Retinal Vein Occlusion will undergo vitrectomy, a small needle of about 71 micron will enter a branch retinal vein and TPA will be injected into the obstracted vein.
Read the detailed description
Patients with Central Retinal Vein Occlusion less than 6 month duration and reduction of vision to 6/21 will go OCT and FANG examinations.
Patient will be operated vitrectomy, and a branch retinal vein will be punctured by small needle and rTPA 200mcg/ml will be injected to the vein.
- Conditions
- Central Retinal Vein Occlusion
- Being tested
- Retinal endo vascular surgery
- Keywords
- retinal vein occlusion, rTPA
- 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.
Retinal endo vascular surgeryProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
Amount of macular edema.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2006 (estimated)
- Study startOct 2006
- Study completionOct 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Retinal Vein OcclusionStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Michael halpert, Study chair, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00383773
- Sponsor's protocol ID
- 1yumbo-HMO-CTIL
- Status last verified
- Sep 2006
- First submitted
- 3 Oct 2006
- Last updated
- 4 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retinal Endo Vascular Surgery for Central Retinal Vein Occlusion
- ClinicalTrials.gov ID
- NCT00383773
- Acronym / sponsor ID
- 1yumbo-HMO-CTIL
- Conditions
- Central Retinal Vein Occlusion
- Keywords
- retinal vein occlusion, rTPA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Oct 2006
- Study completion
- Oct 2007 (estimated)
- First posted
- 4 Oct 2006 (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.
Patients with Central Retinal Vein Occlusion will undergo vitrectomy, a small needle of about 71 micron will enter a branch retinal vein and TPA will be injected into the obstracted vein.
Detailed description
Patients with Central Retinal Vein Occlusion less than 6 month duration and reduction of vision to 6/21 will go OCT and FANG examinations.
Patient will be operated vitrectomy, and a branch retinal vein will be punctured by small needle and rTPA 200mcg/ml will be injected to the vein.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- crvo less than 6 month
- Visual Acuity less than 6/21
- No prior eye surgery except cataract.
Key exclusion criteria (1 listed)
- Retinal/iris neovascularization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retinal endo vascular surgery | Procedure or surgery | – |
Primary outcome
Visual acuity
Amount of macular edema.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2006.
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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.
Michael halpert study chair
Hadassah Medical Organization
Questions about this trial
What is this clinical trial studying?
A study testing Retinal endo vascular surgery in people with Central Retinal Vein Occlusion, run by Hadassah Medical Organization.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 4 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Halpert, MD. (00972507874385, halpert@cc.huji.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity. The study lists 2 primary outcomes in all. 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 4 Oct 2006.