Condition category
Eye Diseases
Date applied
08/05/2007
Date assigned
23/07/2007
Last edited
24/07/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Shivam Maini

ORCID ID

Contact details

3/198 Vishnupuri
Kanpur
208002
India

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ACRVOS

Study information

Scientific title

Acronym

ACRVOS (Atorvastatin for CRVO Study)

Study hypothesis

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.

Ethics approval

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.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Central Retinal Vein Occlusion

Intervention

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.

Intervention type

Drug

Phase

Not Specified

Drug names

Atorvastatin

Primary outcome measures

1. Visual acuity
2. Tortuosity of retinal veins

Secondary outcome measures

Recurrence of Central Retinal Vein Occlusion

Overall trial start date

10/05/2007

Overall trial end date

09/05/2009

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

50

Participant exclusion criteria

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.

Recruitment start date

10/05/2007

Recruitment end date

09/05/2009

Locations

Countries of recruitment

India

Trial participating centre

3/198 Vishnupuri
Kanpur
208002
India

Sponsor information

Organisation

J L Rohatgi Eye Hospital (India)

Sponsor details

Sarvodaya Nagar
Kanpur
208002
India
jlrhospital@hotmail.com

Sponsor type

Hospital/treatment centre

Website

http://www.jlrohatgihospital.org/

Funders

Funder type

Hospital/treatment centre

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes