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

This study has been terminated.
(lack of recruting)
Sponsor:
Information provided by:
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT00379223
First received: September 20, 2006
Last updated: March 3, 2011
Last verified: August 2008
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 26, 2014