Condition category
Injury, Occupational Diseases, Poisoning
Date applied
06/08/2009
Date assigned
23/09/2009
Last edited
12/04/2012
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

Prof Rasik Vajpayee

ORCID ID

Contact details

Centre for Eye Research Australia
University of Melbourne
Royal Victorian Eye and Ear Hospital
32
Gisborne Street
East Melbourne
Victoria
Melbourne
3002
Australia
+61 (0)3 9929 8368
rasikv@unimelb.edu.au

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2000-01800

Study information

Scientific title

Evaluation of topical ciclosporin A in prevention of corneal graft rejection: a randomised double blind single centre study

Acronym

Study hypothesis

To evaluate the role of ciclosporin A eye drops in cases with corneal endothelial graft rejection after penetrating keratoplasty.

Ethics approval

Indian Council of Medical Research, New Delhi, India, approved in 2001

Study design

Randomised controlled double blind interventional single-centre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Corneal graft rejection

Intervention

After corneal transplantation surgery, patients in the study group will receive 2% ciclosporin eye drops prepared in 1.4% polyvinyl alcohol every six hours for one year. Patients in the control group will receive 1.4% polyvinyl alcohol eye drop (placebo drops) every 6 hours for a similar duration.

Intervention type

Drug

Phase

Not Specified

Drug names

Ciclosporin A

Primary outcome measures

incidence of occurrence of corneal endothelial graft rejection after high-risk keratoplasty in the study and control group at the end of one year.

Secondary outcome measures

1. Incidence of reversal of graft rejection in the study and control group at the end of one year
2. Incidence of occurrence possible side effects of using ciclosporin A eye drops in the study group at the end of one year

Overall trial start date

01/08/2001

Overall trial end date

31/01/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients greater than or equal to 9 years of age, either sex
2. Eyes undergoing penetrating keratoplasty
3. With two or more quadrants of corneal vascularisation extending at least 2 mm into the cornea
4. Cases of corneal re-grafts

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

84 patients

Participant exclusion criteria

1. Grafts that are not high-risk
2. Pregnant/lactating females
3. Children below 9 years of age
4. Patients who refused to give consent

Recruitment start date

01/08/2001

Recruitment end date

31/01/2005

Locations

Countries of recruitment

India

Trial participating centre

Centre for Eye Research Australia
Melbourne
3002
Australia

Sponsor information

Organisation

Indian Council of Medical Research (ICMR) (India)

Sponsor details

V. Ramalingaswami Bhawan
Ansari Nagar
New Delhi
110029
India
+91 (0)11 2658 8895
headquarters@icmr.org.in

Sponsor type

Research council

Website

http://icmr.nic.in/home.htm

Funders

Funder type

Research council

Funder name

Indian Council of Medical Research (ICMR) (India) (ref: 2000-01800)

Alternative name(s)

ICMR

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

India

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

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20414783

Publication citations

  1. Results

    Sinha R, Jhanji V, Verma K, Sharma N, Biswas NR, Vajpayee RB, Efficacy of topical cyclosporine A 2% in prevention of graft rejection in high-risk keratoplasty: a randomized controlled trial., Graefes Arch. Clin. Exp. Ophthalmol., 2010, 248, 8, 1167-1172, doi: 10.1007/s00417-010-1388-8.

Additional files

Editorial Notes