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ISRCTN
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ISRCTN61985307
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ClinicalTrials.gov identifier
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Public title
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Role of Atorvastatin for treatment of Central Retinal Vein Occlusion and long term prognosis
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Scientific title
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Acronym
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ACRVOS (Atorvastatin for CRVO Study)
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Serial number at source
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ACRVOS
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Study hypothesis
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It has been suggested that in some instances an atherosclerotic central retinal artery impinges on the central vein, causing turbulence, endothelial damage and thrombus formation. Atorvastatin, with its lipid lowering action, may help in reducing the impingement on central retinal vein and therefore help in restoring the normal blood flow. Apart from the primary hypothesis, the protective role on endothelium may also be a determining factor for the final visual outcome.
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Ethics approval
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Ethics approval was not applied for since we don't have such a body here in India. Also, since the drug we plan to try is being prescribed for various other pathologies, this is just another indication which we might come up with.
This particular trial is the first one of the use of this drug for the given problem. There has not even been a case report of the drug use for CRVO. Since we have deeply studied the pathology of the disease and the action of the drug, we are expecting a positive response.
The patients will be fully informed of the nature of the treatment and only after consent will the drug be used.
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Study design
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Randomised controlled trial
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Countries of recruitment
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India
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Disease/condition/study domain
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Central Retinal Vein Occlusion
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Participants - inclusion criteria
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Patients with:
1. Central Retinal Vein Occlusion (CRVO) of more than one day duration
2. No other ophthalmic pathologies
3. No contraindication to atorvastatin
4. No prior use of statins
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Participants - exclusion criteria
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Patients with CRVO of less than one day duration are treated conventionally and those who have other ophthalmic pathologies or patients who have been on atorvastatin or any other statins earlier are not included in any groups.
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Anticipated start date
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10/05/2007
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Anticipated end date
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09/05/2009
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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50
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Interventions
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Intervention treatment:
Duration of atorvastatin planned to be given is for two months. Dosage is to be 10 mg per day, given once in a day, orally.
Control treatment:
Treatment as usual.
Both groups will be subject to Laser pan-retinal photocoagulation and regular protocol in case of any complications arising from CRVO.
Follow up will be for every third/fourth day upto a maximum of 15 days from the date of incident and then once every week for a period of month. A late follow up is planned at six months from the incident of CRVO and at one year.
Patients who report to us within 24 hours of CRVO will receive the regular care and treatment so as to release/dissolve the clot and restore normal flow and such cases will obviously be not included in any group. Since this treatment is usually not effective after a few hours, we have planned our study for cases presenting at a late stage and for long term prognosis.
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Primary outcome measure(s)
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1. Visual acuity
2. Tortuosity of retinal veins
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Secondary outcome measure(s)
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Recurrence of Central Retinal Vein Occlusion
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Sources of funding
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J L Rohatgi Memorial Eye Hospital (India) and investigator funded trial
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Trial website
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Publications
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Contact name
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Dr
Shivam
Maini
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Address
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3/198 Vishnupuri
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City/town
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Kanpur
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Zip/Postcode
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208002
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Country
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India
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Sponsor
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J L Rohatgi Eye Hospital (India)
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Address
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Sarvodaya Nagar
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City/town
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Kanpur
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Zip/Postcode
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208002
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Country
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India
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Email
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jlrhospital@hotmail.com
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Sponsor website:
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http://www.jlrohatgihospital.org/
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Date applied
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08/05/2007
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Last edited
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24/07/2007
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Date ISRCTN assigned
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23/07/2007
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