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Topical ciclosporin A eye drops for graft rejection

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN52781697
Enrollment
84
Registered
2009-09-23
Start date
2001-08-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Corneal graft rejection Injury, Occupational Diseases, Poisoning Failure and rejection of transplanted organs and tissues

Interventions

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

Sponsors

Indian Council of Medical Research (ICMR) (India)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

India

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026