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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 1 (PKP study) B. Evaluation of the efficacy of 2% cyclosporine in preventing graft rejection in therapeutic keratoplasty- study 2(TKP study) Materials & Methods: In both arms Patients requiring keratoplasty, above the age of 18 whom satisfactorily meet The inclusion criteria are different for each study Eligible candidates will be enrolled after signing an Informed Consent form Patients will be randomized into one of 2 groups
Only on topical steroids group A
On topical steroids + 2% cyclosporine Group B Study design: Prospective, randomized non-blinded study at a single centre. Methodology In both arms
1. Schedule of topical steroid administration : 6 times for 2 weeks; 5 times for 2 weeks; 4 times for a month; 3 times for a month, and, subsequently twice-a-day until 1 year is completed Systemic steroids may be administered in the initial 2 weeks at the discretion of the investigators. (For all patients with fungal keratitis topical steroids can preferrably be administered only after 2 weeks post keratoplasty.) Until then voveran ophtha may be used
3. Patients randomized to receive 2% cyclosporine will receive the same 3 times a day for 2years
4. All patients will be followed for a minimum period of 2 years
5. Follow up schedule - at 1 week, 2 weeks, 1 month, 2 months, 3 months, then every 3 months until 2 years are completed
6. All episodes of graft rejection will be treated as per accepted norms and the patient will no longer follow the standardized protocol for steroid administration
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| penetrating keratoplasty | Active Comparator | each arm will have two groups A and B.. Only on topical steroids(prednisolone acetate1%) group A On topical steroids + 2% cyclosporine Group B . Methodology of drug administration In both agroups 1. Schedule of topical steroid administration : 6 times for 2 weeks; 5 times for 2 weeks; 4 times for a month; 3 times for a month, and, subsequently twice-a-day until 1 year is completed . Topical steroids will be withdrawn at the end of ine year.Systemic steroids may be administered in the initial 2 weeks at the discretion of the investigators. 3. Patients randomized to receive 2% cyclosporine will receive the same 3 times a day for 2years . |
|
| therapeutic keratoplasty | Active Comparator | each arm will have two groups A and B.. Only on topical steroids(prednisolone acetate1%) group A On topical steroids + 2% cyclosporine Group B . Methodology of drug administration In both agroups 1. Schedule of topical steroid administration : 6 times for 2 weeks; 5 times for 2 weeks; 4 times for a month; 3 times for a month, and, subsequently twice-a-day until 1 year is completed . Topical steroids will be withdrawn at the end of ine year.Systemic steroids may be administered in the initial 2 weeks at the discretion of the investigators. (For all patients with fungal keratitis topical steroids will be administered only after 2 weeks post keratoplasty.) Until then diclofenac sodium0.1% may be used 3. Patients randomized to receive 2% cyclosporine will receive the same 3 times a day for 2years . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prednisolone acetate1%, | Drug | efficacy of prednisolone acetate1%alone versus prednisolone acetate 1%and cyclosporine 2% in preventing graft rejection |
|
| Measure | Description | Time Frame |
|---|---|---|
| graft rejection | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| recovery from graft rejection | 5 years | |
| Incidence of graft rejection in patients maintained only on cyclosporine after 1year | .graft rejection in patients only on cyclosporine 2% eye drops in the second year of study |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of glaucoma and cataract. | 5 years |
Inclusion Criteria:
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
Exclusion Criteria: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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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| dr.anita raghavan | Contact | 04224360400 | 407 | annieram2001@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Dr.Anita Raghavan | Medical Cornea Consultant | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr.Anita Raghavan | Recruiting | Coimbatore | Tamil Nadu | 641014 | India |
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| ID | Term |
|---|---|
| C009935 | prednisolone acetate |
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|
| Prednisolone acetate1%, cyclosporine 2% | Drug | penetrating keratoplasty--efficacy of prednisolone acetate1%alone versus prednisolone acetate 1%and cyclosporine 2% in preventing graft rejection |
|
|
| 5 years |