OVCR: Radial Optic Neurotomy in Central Retinal Vein Occlusion : a Randomized Trial

Sponsor

University Hospital, Bordeaux (Other)

Overall Status

Terminated

CT.gov ID

NCT00379223

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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. The primary outcome will be vision measured 6 months after surgery.

Condition or Disease	Intervention/Treatment	Phase
Retinal Vein Occlusion	Procedure: vitrectomy with radial optic neurotomy	N/A

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

Study Type:

Interventional

Actual Enrollment :

7 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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)

Study Start Date :

Oct 1, 2006

Actual Primary Completion Date :

Sep 1, 2008

Actual Study Completion Date :

Sep 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

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]

Secondary Outcome Measures

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) []
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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