Modification of ocular graft-versus-host disease development by early local Cyclosporin A application in patients after donor stem cell transplant.
- Conditions
- Ocular GVHDPreventive treatmentTopical Cyclosporine A
- Registration Number
- NL-OMON28561
- Lead Sponsor
- MC UtrechtHeidelberglaan 1003584 CX UtrechtThe Netherlands
- Brief Summary
Current insights into ocular graft-versus-host disease Anjo Riemens, Liane te Boome, Saskia Imhof, Jurgen Kuball;<br>Aniki Rothova<br> Current Opinion in Ophthalmology 2010, 21:000–000.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 102
Inclusion Criteria
Patients > 18 yrs who have undergone donor stem cell transplant for haematological malignancy or bone marrow failure disorder.
Exclusion Criteria
1. History of Sjögren’s syndrome;
2. Documented dry eye prior to stem cell transplantation / significant non-GVHD ocular problems;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To investigate the potential efficacy of topical cyclosporine A 0.05% (Restasis) application in preventing ocular surface disease in ocular chronic GVHD in patients who have undergone donor stem cell transplantation an compare this to the effect of preventive treatment with Vidisic PVP Ophtiole eye drops.
- Secondary Outcome Measures
Name Time Method 1. Evaluate the safety and frequency of side effects of Cyclosporine A;<br /><br>2. Evaluate the correlation of ocular GVHD symptoms in relation to GVHD symptoms in general.