Status:
UNKNOWN
Evaluation of the Efficacy of 2% Cyclosporine in Preventing Graft Rejection
Lead Sponsor:
Aravind Eye Care System
Conditions:
Corneal Graft Rejection
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Aim/ Objective: Study consists of 2 separate and distinct entities A. Evaluation of the efficacy of 2% cyclosporine in preventing graft rejection in primary grafts w/o high risk characteristics study ...
Eligibility Criteria
Inclusion
- FOR ARM 1
- Age greater than 18 years
- Vision more than 6/60 in the fellow eye.
- No prior keratoplasty
- Not more than 1 quadrant of corneal vascularisation
- No peripheral anterior synechiae.
- No active ocular surface disease (VKC, dry eye,)
- Uncontrolled uveitis or glaucoma
- No limbal stem cell failure.
- No Prior h/o HSV
- Primarily patients with dystrophies, degenerations and pseudophakic bullous keratopathy and non vascularised non herpetic corneal scars will be enrolled
- ARM 2:
- Inclusion criteria as above \&
- Those patients with medically unresponsive keratitis with no limbal involvement and in whom the graft size can be restricted to less than 9mm will be included in the study. This is to ensure that postoperative issues such as synechiae, recurrence of infection and uncontrolled glaucoma do not affect the study. Grafts must also be clear at the end of one month after surgery for patients to continue in the study..
- Expected Outcome
- Incidence of graft rejection in both arms.
- secondary outcome Recovery from graft rejection in both arms.
- Secondary outcomes- incidence of glaucoma and cataract.
- secondary outcome Incidence of graft rejection in patients maintained only on cyclosporine after 1year.
- It is expected that patients receiving cyclosporine will have a lesser incidence of graft rejection and exhibit faster recovery. The efficacy of long term prophylaxis of only cyclosporine in preventing graft rejection will also be evaluated.
Exclusion
- Any condition that would increase the risk of non-rejection graft failure such as Stevens-Johnson syndrome, xerophthalmia or severe exposure keratitis. Schirmer's test ≤ 5 mm in 1 minute Clinical evidence of limbal stem cell deficiency History of or active herpes simplex virus keratitis or other acute corneal infection
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Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2017
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT02206789
Start Date
February 1 2012
End Date
December 1 2017
Last Update
August 1 2014
Active Locations (1)
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1
Dr.Anita Raghavan
Coimbatore, Tamil Nadu, India, 641014