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

Primary Purpose

Retinal Vein Occlusion

Status

Terminated

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

vitrectomy with radial optic neurotomy

About this trial

This is an interventional treatment trial for Retinal Vein Occlusion focused on measuring retinal vein occlusion, vitrectomy, surgery, retinal disorders, vascular diseases

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Arm Description

Standard treatment of central retinal vein occlusion : the rheologic correction

Standard treatment of central retinal vein occlusion : the rheologic correction and surgery associating pars plana vitrectomy and radial optic neurotomy

Outcomes

Primary Outcome Measures

Proportion of patients showing an improvement of visual acuity (at least 3 lines (15 letters) in ETDRS charts)

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.

Full Information

NCT ID

NCT00379223

First Posted

September 20, 2006

Last Updated

March 3, 2011

Sponsor

University Hospital, Bordeaux

1. Study Identification

Unique Protocol Identification Number

NCT00379223

Brief Title

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

Acronym

OVCR

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 Type

Interventional

2. Study Status

Record Verification Date

August 2008

Overall Recruitment Status

Terminated

Why Stopped

lack of recruting

Study Start Date

October 2006 (undefined)

Primary Completion Date

September 2008 (Actual)

Study Completion Date

September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University Hospital, Bordeaux

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Retinal Vein Occlusion

Keywords

retinal vein occlusion, vitrectomy, surgery, retinal disorders, vascular diseases

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

No Intervention

Arm Description

Standard treatment of central retinal vein occlusion : the rheologic correction

Arm Title

Arm Type

Experimental

Arm Description

Standard treatment of central retinal vein occlusion : the rheologic correction and surgery associating pars plana vitrectomy and radial optic neurotomy

Intervention Type

Procedure

Intervention Name(s)

vitrectomy with radial optic neurotomy

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Efficacy

Time Frame

between pre operative examination and 6 months after randomization

Title

Mean visual acuity

Time Frame

between pre operative examination and 6 months

Title

Macular thickness in Optical Coherence Tomography (OCT)

Title

Persistence of hemorrhages in the fundus

Title

Retinal ischemia indicating pan retinal photocoagulation

Time Frame

6 months after randomization

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jean François KOROBELNIK, Pr

Organizational Affiliation

University Hospital, Bordeaux

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Geneviève CHENE, pR

Organizational Affiliation

University Hospital, Bordeaux

Official's Role

Study Chair

Facility Information:

Facility Name

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

City

Bordeaux

ZIP/Postal Code

33076

Country

France

12. IPD Sharing Statement

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

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