Role of Atorvastatin for treatment of Central Retinal Vein Occlusion and long term prognosis

ISRCTN ISRCTN61985307
DOI https://doi.org/10.1186/ISRCTN61985307
Secondary identifying numbers ACRVOS
Submission date
08/05/2007
Registration date
23/07/2007
Last edited
15/12/2017
Recruitment status
Stopped
Overall study status
Stopped
Condition category
Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Shivam Maini
Scientific

3/198 Vishnupuri
Kanpur
208002
India

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleRole of Atorvastatin for treatment of Central Retinal Vein Occlusion and long term prognosis
Study acronymACRVOS (Atorvastatin for CRVO Study)
Study objectivesIt 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.
Ethics approval(s)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.
Health condition(s) or problem(s) studiedCentral Retinal Vein Occlusion
InterventionIntervention 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.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Atorvastatin
Primary outcome measure1. Visual acuity
2. Tortuosity of retinal veins
Secondary outcome measuresRecurrence of Central Retinal Vein Occlusion
Overall study start date10/05/2007
Completion date09/05/2009
Reason abandoned (if study stopped)Lack of staff/facilities/resources

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants50
Key inclusion criteriaPatients 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
Key exclusion criteriaPatients 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.
Date of first enrolment10/05/2007
Date of final enrolment09/05/2009

Locations

Countries of recruitment

  • India

Study participating centre

3/198 Vishnupuri
Kanpur
208002
India

Sponsor information

J L Rohatgi Eye Hospital (India)
Hospital/treatment centre

Sarvodaya Nagar
Kanpur
208002
India

Email jlrhospital@hotmail.com
Website http://www.jlrohatgihospital.org/

Funders

Funder type

Hospital/treatment centre

J L Rohatgi Memorial Eye Hospital (India) and investigator funded trial

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

15/12/2017: This study was not initiated due to internal problems.