NCT00379223

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 21, 2006

Completed
10 days until next milestone

Study Start

First participant enrolled

October 1, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

March 4, 2011

Status Verified

August 1, 2008

Enrollment Period

1.9 years

First QC Date

September 20, 2006

Last Update Submit

March 3, 2011

Conditions

Retinal Vein Occlusion

Keywords

retinal vein occlusionvitrectomysurgeryretinal disordersvascular diseases

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

1

NO INTERVENTION

Standard treatment of central retinal vein occlusion : the rheologic correction

2

EXPERIMENTAL

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

Interventions

vitrectomy with radial optic neurotomyPROCEDURE
2

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service d'ophtalmologie, Hopital Pellegrin, place Amélie Raba Léon

Bordeaux, 33076, France

Location

MeSH Terms

Conditions

Retinal Vein OcclusionRetinal DiseasesVascular Diseases

Interventions

Vitrectomy

Condition Hierarchy (Ancestors)

Eye DiseasesVenous ThrombosisThrombosisEmbolism and ThrombosisCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Jean François KOROBELNIK, Pr

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

  • Geneviève CHENE, pR

    University Hospital, Bordeaux

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 20, 2006

First Posted

September 21, 2006

Study Start

October 1, 2006

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

March 4, 2011

Record last verified: 2008-08

Locations

FR(1)