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| ID | Type | Description | Link |
|---|---|---|---|
| 2004-028 |
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lack of recruting
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vitrectomy with radial optic neurotomy | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients showing an improvement of visual acuity (at least 3 lines (15 letters) in ETDRS charts) | between pre operative examination and 6 months after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy | between pre operative examination and 6 months after randomization | |
| Mean visual acuity | between pre operative examination and 6 months | |
| Macular thickness in Optical Coherence Tomography (OCT) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean François KOROBELNIK, Pr | University Hospital, Bordeaux | Principal Investigator |
| Geneviève CHENE, pR | University Hospital, Bordeaux | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service d'ophtalmologie, Hopital Pellegrin, place Amélie Raba Léon | Bordeaux | 33076 | France |
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| ID | Term |
|---|---|
| D012170 | Retinal Vein Occlusion |
| D012164 | Retinal Diseases |
| D014652 | Vascular Diseases |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
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| ID | Term |
|---|---|
| D014821 | Vitrectomy |
| ID | Term |
|---|---|
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Persistence of hemorrhages in the fundus |
| Retinal ischemia indicating pan retinal photocoagulation | 6 months after randomization |
| Safety : Serious complications after surgery (retinal detachment, retinal ischemia, neovascular glaucoma) or medical treatment during the 6 months following surgery. | after surgery or medical treatment examination and 6 months after randomization |
| D002318 |
| Cardiovascular Diseases |