Radial Optic Neurotomy in Central Retinal Vein Occlusion : a Randomized Trial - Full Text View

Sponsored by:	University Hospital, Bordeaux
Information provided by:	University Hospital, Bordeaux
ClinicalTrials.gov Identifier:	NCT00379223

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

MedlinePlus related topics: Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy 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)

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 ]

Secondary Outcome Measures:

Efficacy
Mean visual acuity
Macular thickness in Optical Coherence Tomography (OCT)
Persistence of hemorrhages in the fundus
Retinal ischemia indicating pan retinal photocoagulation
Safety : Serious complications after surgery (retinal detachment, retinal ischemia, neovascular glaucoma) or medical treatment during the 6 months following surgery.

Estimated Enrollment:	60
Study Start Date:	October 2006
Estimated Study Completion Date:	August 2008

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

Contacts

Contact: Jean françois KOROBELNIK, Pr

33 (0) 5 56 79 57 41

jean-francois.korobelnik@chu-bordeaux.fr

Locations

France
Service d'ophtalmologie, Hopital Pellegrin, place Amélie Raba Léon	Recruiting
Bordeaux, France, 33076
Contact: Jean François Korobelnik, Pr. 33 (0) 5 56 79 57 41 jean-francois.korobelnik@chu-bordeaux.fr
Principal Investigator: Jean Francois Korobelnik, Pr.

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

Study ID Numbers:	9418-04, 2004-028
Study First Received:	September 20, 2006
Last Updated:	June 28, 2007
ClinicalTrials.gov Identifier:	NCT00379223 History of Changes
Health Authority:	France: Ministry of Health

Keywords provided by University Hospital, Bordeaux:

retinal vein occlusion
vitrectomy
surgery
retinal disorders
vascular diseases

Study placed in the following topic categories:

Embolism and Thrombosis
Embolism
Eye Diseases
Retinal Vein Occlusion

Vascular Diseases
Venous Thrombosis
Thrombosis
Retinal Diseases

Additional relevant MeSH terms:

Embolism and Thrombosis
Eye Diseases
Retinal Vein Occlusion
Vascular Diseases

Cardiovascular Diseases
Venous Thrombosis
Thrombosis
Retinal Diseases

ClinicalTrials.gov processed this record on May 07, 2009