Radial Optic Neurotomy in Central Retinal Vein Occlusion : a Randomized Trial (OVCR)
This study has been terminated.
(lack of recruting)
Sponsor:
University Hospital, Bordeaux
Information provided by:
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT00379223
First received: September 20, 2006
Last updated: March 3, 2011
Last verified: August 2008
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Retinal Vein Occlusion |
Procedure: vitrectomy with radial optic neurotomy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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) |
Resource links provided by NLM:
Further study details as provided by University Hospital, Bordeaux:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Efficacy [ Time Frame: between pre operative examination and 6 months after randomization ] [ Designated as safety issue: No ]
- Mean visual acuity [ Time Frame: between pre operative examination and 6 months ] [ Designated as safety issue: No ]
- Macular thickness in Optical Coherence Tomography (OCT) [ Designated as safety issue: No ]
- Persistence of hemorrhages in the fundus [ Designated as safety issue: No ]
- Retinal ischemia indicating pan retinal photocoagulation [ Time Frame: 6 months after randomization ] [ Designated as safety issue: No ]
- 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 ]
| Enrollment: | 7 |
| Study Start Date: | October 2006 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: 1
Standard treatment of central retinal vein occlusion : the rheologic correction
|
|
|
Experimental: 2
Standard treatment of central retinal vein occlusion : the rheologic correction and surgery associating pars plana vitrectomy and radial optic neurotomy
|
Procedure: vitrectomy with radial optic neurotomy |
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.
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00379223
Locations
| France | |
| Service d'ophtalmologie, Hopital Pellegrin, place Amélie Raba Léon | |
| Bordeaux, France, 33076 | |
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
| Principal Investigator: | Jean François KOROBELNIK, Pr | University Hospital, Bordeaux |
| Study Chair: | Geneviève CHENE, pR | University Hospital, Bordeaux |
More Information
No publications provided
| Responsible Party: | Jean Pierre LEROY/Clinical Research and innovation Director, University Hospital Bordeaux |
| ClinicalTrials.gov Identifier: | NCT00379223 History of Changes |
| Other Study ID Numbers: | 9418-04, 2004-028 |
| Study First Received: | September 20, 2006 |
| Last Updated: | March 3, 2011 |
| Health Authority: | France: Ministry of Health |
Keywords provided by University Hospital, Bordeaux:
|
retinal vein occlusion vitrectomy surgery retinal disorders vascular diseases |
Additional relevant MeSH terms:
|
Retinal Vein Occlusion Retinal Diseases Eye Diseases Venous Thrombosis |
Thrombosis Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 23, 2013