Topical ciclosporin A eye drops for graft rejection
| ISRCTN | ISRCTN52781697 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52781697 |
| Protocol serial number | 2000-01800 |
| Sponsor | Indian Council of Medical Research (ICMR) (India) |
| Funder | Indian Council of Medical Research (ICMR) (India) (ref: 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled double blind interventional single-centre trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Ciclosporin A |
| Primary outcome measure(s) |
incidence of occurrence of corneal endothelial graft rejection after high-risk keratoplasty in the study and control group at the end of one year. |
| Key secondary outcome measure(s) |
1. Incidence of reversal of graft rejection in the study and control group at the end of one year |
| Completion date | 31/01/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | All |
| Target sample size at registration | 84 |
| 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
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2010 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
