Efficacy of Topical Cyclosporine A for Treatment and Prevention of Graft Rejection in Corneal Grafts With Previous Rejection Episodes

Sponsor
Shahid Beheshti University of Medical Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT01028443
Collaborator
(none)
2
2

Study Details

Study Description

Brief Summary

The use of topical Cyclosporine A early after an episode of endothelial graft rejection after penetrating keratoplasty and continuing its administration for 6 months can reduce the course of that episode and recurrence of the rejection.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Cyclosporine A 2%

Drug: Sandimmune

Placebo Comparator: Artificial tears

Drug: Artelose

Outcome Measures

Primary Outcome Measures

  1. The rate of rejection after drop sessation [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
  • Penetrating keratoplasty in eyes without vascularization
Exclusion Criteria:
  • History of previous intraocular surgery

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ophthalmic Research Center Tehran Iran, Islamic Republic of 166666
2 Ophthalmic Research Center Tehran Iran, Islamic Republic of 16666

Sponsors and Collaborators

  • Shahid Beheshti University of Medical Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01028443
Other Study ID Numbers:
  • 8546
First Posted:
Dec 9, 2009
Last Update Posted:
Dec 9, 2009
Last Verified:
Apr 1, 2006
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 9, 2009