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Prevalence and Risk of Cataracts in Granulocyte Donors

NCT00042627 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 252

Last updated 2017-07-02

No results posted yet for this study

Summary

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

Conditions

  • Apheresis

Sponsors & Collaborators

  • National Eye Institute (NEI)

    lead NIH

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-07-30
Completion
2007-06-25

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00042627 on ClinicalTrials.gov