Prevalence and Risk of Cataracts in Granulocyte Donors
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|ClinicalTrials.gov Identifier: NCT00042627|
Recruitment Status : Completed
First Posted : August 2, 2002
Last Update Posted : July 2, 2017
This study will investigate whether people who donate granulocytes (a type of white blood cell) by leukapheresis are at increased risk of developing cataracts (changes in the lens of the eye that can impair vision). Apheresis is a method of collecting large numbers of white blood cells. The procedure is similar to donating whole blood, but the collected blood is circulated through a cell separator machine, the white cells are extracted, and the rest of the blood is returned to the donor. Before the procedure, donors are given a steroid called dexamethasone. This drug temporarily increases the number of granulocytes circulating in the blood, thus allowing twice as many of these cells to be collected.
Recently, one blood collection center reported greater numbers of cataracts in a small number of granulocyte donors who had received repeated doses of steroids for granulocyte mobilization. The donors were unaware that they had the cataracts, which were small and did not affect their vision. Although people who take high doses of steroids over a long period time are known to have an increased risk of cataracts, steroids given infrequently (and in the doses used for granulocyte donation) have not been associated with cataracts. This study will examine the eyes of granulocyte donors and of platelet donors. Platelets-blood components necessary for clotting-are also collected by pheresis, but donors are not given steroids before the procedure. The examination findings will be compared to see if there is a difference in the risk of cataract formation in the two groups.
People 18 years of age and older who have donated granulocytes or platelets at the NIH Department of Transfusion Medicine four times or more since 1984 may be eligible for this study. Participants will undergo the following procedures:
- Detailed medical history, including allergies, corticosteroid use, diabetes mellitus, and asthma
- Detailed eye history, including cataracts, glaucoma, other eye diseases and infections, eye trauma, and corrective lenses
- Detailed history of sun exposure
- Eye examination, including measurement of visual acuity (eye chart test) and eye pressure, examination of the lens and retina.
- Photographs of the eye using a special camera
|Condition or disease|
|Study Type :||Observational|
|Enrollment :||252 participants|
|Official Title:||Prevalence and Risks for Posterior Subcapsular Cataracts in Volunteer Granulocytapheresis Donors|
|Study Start Date :||July 30, 2002|
|Study Completion Date :||June 25, 2007|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00042627
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|