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 measure
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 (if study stopped)
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
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 organizations
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
Basic results (scientific)
Publication list
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20414783
Publication citations
-
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.