Retinal Vein OcclusionOVCRNCT00379223
Radial Optic Neurotomy in Central Retinal Vein Occlusion : a Randomized Trial
A study testing vitrectomy with radial optic neurotomy in people with Retinal Vein Occlusion, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Natural evolution of severe central retinal vein occlusion with low visual acuity is very poor. A randomized clinical trial will compare troxerutin and platelet anti-aggregating agents (drug treatment) versus surgery and drug treatment. Surgery will include vitrectomy and radial optic neurotomy. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Retinal Vein Occlusion
- What is being tested?
- vitrectomy with radial optic neurotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2006to Sep 2008
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Central Retinal Vein Occlusion oedematous or hemorrhagic (at fundus exam and at fluorescein angiography)
- Visual Acuity (VA) ≤ 20/200 with ETDRS charts
- Decreased VA since more than 1 month, less than 3 months
- Common care recommendations for CRVO during the period before recruitment (Control ocular pressure if associated hypertension or glaucoma ; Hemodilution if hematocrit ≥ 38% ,if no cardio-vascular contra-indication, to maintain hematocrit under 38% during 6 weeks ; Troxerutin (3 /d) and aspirin (100 - 160 mg/d) ; Clinical and angiographic controls to look for retinal ischemia indicating laser PRP to prevent neovascular glaucoma.
- Signed informed consent.
Who cannot join
- Ischemic CRVO : 1- More than 30 disc diameters of ischemia at fluorescein angiography and/or •2- If Angiogram is uninterpretable because of hemorrhages, deficit of afferent pupillary reflex 0.9 with photographic filters (proposed by Hayreh) with indication to do laser PRP or laser PRP already done,
- Rubeosis or neovascular glaucoma,
- Bilateral diabetic retinopathy preproliferative or proliferative,
- Uncharacterized coagulation disease, or anticoagulant treatment,
- Untreated systemic disease (diabetes, severe high blood pressure, Cardiac failure) ou eye disease (glaucoma),
- Contra-indication or documented allergy to troxerutin or platelet anti-aggregating agents,
- Contra-indication to surgical procedure
- incapacity to received an informed consent, incapacity to follow all the study schedule
Trial locations and contacts
1 site in 1 country.
France1 site
Service d'ophtalmologie, Hopital Pellegrin, place Amélie Raba Léon
Bordeaux, 33076
About this study
Official title: Multicenter Trial to Investigate the Safety and Efficacy of Vitrectomy With Radial Optic Neurotomy for the Preservation of Visual Function in Subjects With Central Retinal Vein Occlusion (CRVO)
Natural evolution of severe central retinal vein occlusion with low visual acuity is very poor. A randomized clinical trial will compare troxerutin and platelet anti-aggregating agents (drug treatment) versus surgery and drug treatment. Surgery will include vitrectomy and radial optic neurotomy. The primary outcome will be vision measured 6 months after surgery.
Read the detailed description
Central Retinal Vein Occlusion (CRVO) is the second most frequently retinal vascular disease causing loss of vision, after diabetic retinopathy. No treatment of CRVO has clearly demonstrated beneficial and long lasting visual results. Commonly used treatment options are platelet anti-aggregating agents, correcting rheologic factors with troxerutin and isovolumic hemodilution. Surgical treatment of CRVO has recently been proposed (2001) and has been studied in numerous non comparative pilot studies. Limited but encouraging results motivate our randomised controlled trial. We will evaluate at 6 months visual acuity after surgery associating pars plana vitrectomy and radial optic neurotomy, in patients with central vein occlusion and bad vision, associated with the correction of rheologic factors.
- Conditions
- Retinal Vein Occlusion
- Being tested
- vitrectomy with radial optic neurotomy
- Keywords
- retinal vein occlusion, vitrectomy, surgery, retinal disorders, vascular diseases
- Medical subject headings
- Retinal Vein Occlusion, Retinal Diseases, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitrectomy with radial optic neurotomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Standard treatment of central retinal vein occlusion : the rheologic correction |
| 2 | Experimental | Standard treatment of central retinal vein occlusion : the rheologic correction and surgery associating pars plana vitrectomy and radial optic neurotomy Receives: Procedure: vitrectomy with radial optic neurotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients showing an improvement of visual acuity (at least 3 lines (15 letters) in ETDRS charts)
Measured: between pre operative examination and 6 months after randomization
Secondary outcomes (6)
Efficacy
Measured: between pre operative examination and 6 months after randomization
Mean visual acuity
Measured: between pre operative examination and 6 months
Macular thickness in Optical Coherence Tomography (OCT)
Persistence of hemorrhages in the fundus
Retinal ischemia indicating pan retinal photocoagulation
Measured: 6 months after randomization
Safety : Serious complications after surgery (retinal detachment, retinal ischemia, neovascular glaucoma) or medical treatment during the 6 months following surgery.
Measured: after surgery or medical treatment examination and 6 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2006 (estimated)
- Study startOct 2006
- Primary completionSep 2008
- Study completionSep 2008
Why it stopped: lack of recruting
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal Vein OcclusionStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Investigators
- Jean François KOROBELNIK, Pr, Principal investigator, University Hospital, BordeauxGeneviève CHENE, pR, Study chair, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00379223
- Sponsor's protocol ID
- 9418-04
- Other IDs
- 2004-028
- Acronym
- OVCR
- Status last verified
- Aug 2008
- First submitted
- 20 Sep 2006
- Last updated
- 4 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Trial to Investigate the Safety and Efficacy of Vitrectomy With Radial Optic Neurotomy for the Preservation of Visual Function in Subjects With Central Retinal Vein Occlusion (CRVO)
- ClinicalTrials.gov ID
- NCT00379223
- Acronym / sponsor ID
- OVCR / 9418-04
- Conditions
- Retinal Vein Occlusion
- Keywords
- retinal vein occlusion, vitrectomy, surgery, retinal disorders, vascular diseases
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of recruting
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 21 Sep 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.
Natural evolution of severe central retinal vein occlusion with low visual acuity is very poor. A randomized clinical trial will compare troxerutin and platelet anti-aggregating agents (drug treatment) versus surgery and drug treatment. Surgery will include vitrectomy and radial optic neurotomy. The primary outcome will be vision measured 6 months after surgery.
Detailed description
Central Retinal Vein Occlusion (CRVO) is the second most frequently retinal vascular disease causing loss of vision, after diabetic retinopathy. No treatment of CRVO has clearly demonstrated beneficial and long lasting visual results. Commonly used treatment options are platelet anti-aggregating agents, correcting rheologic factors with troxerutin and isovolumic hemodilution. Surgical treatment of CRVO has recently been proposed (2001) and has been studied in numerous non comparative pilot studies. Limited but encouraging results motivate our randomised controlled trial. We will evaluate at 6 months visual acuity after surgery associating pars plana vitrectomy and radial optic neurotomy, in patients with central vein occlusion and bad vision, associated with the correction of rheologic factors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Standard treatment of central retinal vein occlusion : the rheologic correction |
| 2 | Experimental | Procedure: vitrectomy with radial optic neurotomyStandard treatment of central retinal vein occlusion : the rheologic correction and surgery associating pars plana vitrectomy and radial optic neurotomy |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Central Retinal Vein Occlusion oedematous or hemorrhagic (at fundus exam and at fluorescein angiography)
- Visual Acuity (VA) ≤ 20/200 with ETDRS charts
- Decreased VA since more than 1 month, less than 3 months
- Common care recommendations for CRVO during the period before recruitment (Control ocular pressure if associated hypertension or glaucoma ; Hemodilution if hematocrit ≥ 38% ,if no cardio-vascular contra-indication, to maintain hematocrit under 38% during 6 weeks ; Troxerutin (3 /d) and aspirin (100 - 160 mg/d) ; Clinical and angiographic controls to look for retinal ischemia indicating laser PRP to prevent neovascular glaucoma.
- Signed informed consent.
Key exclusion criteria (8 listed)
- Ischemic CRVO : 1- More than 30 disc diameters of ischemia at fluorescein angiography and/or •2- If Angiogram is uninterpretable because of hemorrhages, deficit of afferent pupillary reflex 0.9 with photographic filters (proposed by Hayreh) with indication to do laser PRP or laser PRP already done,
- Rubeosis or neovascular glaucoma,
- Bilateral diabetic retinopathy preproliferative or proliferative,
- Uncharacterized coagulation disease, or anticoagulant treatment,
- Untreated systemic disease (diabetes, severe high blood pressure, Cardiac failure) ou eye disease (glaucoma),
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 |
|---|---|---|
| vitrectomy with radial optic neurotomy | Procedure or surgery | 2 |
Primary outcome
Proportion of patients showing an improvement of visual acuity (at least 3 lines (15 letters) in ETDRS charts)
Time frame: between pre operative examination and 6 months after randomization
6 secondary outcomes
Efficacy
Time frame: between pre operative examination and 6 months after randomization
Mean visual acuity
Time frame: between pre operative examination and 6 months
Macular thickness in Optical Coherence Tomography (OCT)
Persistence of hemorrhages in the fundus
Retinal ischemia indicating pan retinal photocoagulation
Time frame: 6 months after randomization
Safety : Serious complications after surgery (retinal detachment, retinal ischemia, neovascular glaucoma) or medical treatment during the 6 months following surgery.
Time frame: after surgery or medical treatment examination and 6 months after randomization
Results and safety
The study was stopped early (reason given: lack of recruting). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2011.
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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.
Jean François KOROBELNIK, Pr principal investigator
University Hospital, Bordeaux
Geneviève CHENE, pR study chair
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vitrectomy with radial optic neurotomy in people with Retinal Vein Occlusion, run by University Hospital, Bordeaux at 1 site in France.
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 5 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: stopped early, as of the sponsor's last update on 4 Mar 2011. 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 France. 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 was stopped early (reason given: lack of recruting). Results are not available in the source record.
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?
Proportion of patients showing an improvement of visual acuity (at least 3 lines (15 letters) in ETDRS charts) (time frame: between pre operative examination and 6 months after randomization). 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 Mar 2011.