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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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 O

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.

Detailed Summary: 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.
Sponsor: University Hospital, Bordeaux

Current Primary Outcome: 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 ]

Original Primary Outcome: 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

Current Secondary Outcome:

  • Efficacy [ Time Frame: between pre operative examination and 6 months after randomization ]
  • Mean visual acuity [ Time Frame: 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 [ Time Frame: 6 months after randomization ]
  • 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 ]


Original Secondary Outcome:

  • 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.


Information By: University Hospital, Bordeaux

Dates:
Date Received: September 20, 2006
Date Started: October 2006
Date Completion:
Last Updated: March 3, 2011
Last Verified: August 2008