Topical ciclosporin A eye drops for graft rejection
| ISRCTN | ISRCTN52781697 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52781697 |
| Secondary identifying numbers | 2000-01800 |
- Submission date
- 06/08/2009
- Registration date
- 23/09/2009
- Last edited
- 12/04/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Rasik Vajpayee
Scientific
Scientific
Centre for Eye Research Australia
University of Melbourne
Royal Victorian Eye and Ear Hospital
32, Gisborne Street, East Melbourne
Victoria
Melbourne
3002
Australia
| Phone | +61 (0)3 9929 8368 |
|---|---|
| rasikv@unimelb.edu.au |
Study information
| Study design | Randomised controlled double blind interventional single-centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Evaluation of topical ciclosporin A in prevention of corneal graft rejection: a randomised double blind single centre study |
| Study objectives | To evaluate the role of ciclosporin A eye drops in cases with corneal endothelial graft rejection after penetrating keratoplasty. |
| Ethics approval(s) | Indian Council of Medical Research, New Delhi, India, approved in 2001 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/08/2001 |
| Completion date | 31/01/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | 84 patients |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/08/2001 |
| Date of final enrolment | 31/01/2005 |
Locations
Countries of recruitment
- Australia
- India
Study participating centre
Centre for Eye Research Australia
Melbourne
3002
Australia
3002
Australia
Sponsor information
Indian Council of Medical Research (ICMR) (India)
Research council
Research council
V. Ramalingaswami Bhawan
Ansari Nagar
New Delhi
110029
India
| Phone | +91 (0)11 2658 8895 |
|---|---|
| headquarters@icmr.org.in | |
| Website | http://icmr.nic.in/home.htm |
"ROR" |
https://ror.org/0492wrx28 |
Funders
Funder type
Research council
Indian Council of Medical Research (ICMR) (India) (ref: 2000-01800)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Indian Council of Medical Research, Government of India, Indian Council of Medical Research (ICMR), New Delhi, ICMROrganisation, भारतीय चिकित्सा अनुसंधान परिषद, Indian Council of Medical Research, New Delhi, ICMR, ICMRDELHI, आई.सी.एम.आर
- Location
- India
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2010 | Yes | No |
