Prevalence and Risk of Cataracts in Granulocyte Donors

NCT00042627 | Completed

• 2 other identifiers: 02025502-EI-0255
• Study Type: observational
• Target: 252
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cataracts; Granulocytapheresis; Granulocyte Donors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and understood informed consent.
• Study subjects must be NIH DTM volunteer apheresis donors who have donated granulocytes on 4 or more occasions since 1984.
• Control subjects must be NIH DTM volunteer apheresis donors who have donated platelets on 4 or more occasions since 1984.

You may not qualify if:

• Persons less than 18 years old.
• Persons who have donated granulocytes outside DTM on more than four occasions.
• Persons who have donated platelets outside DTM on more than four occasions.
• Donors with a known history of cataracts will NOT be excluded.

Sponsors & Collaborators

• National Eye Institute (NEI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

• Strauss RG. Therapeutic granulocyte transfusions in 1993. Blood. 1993 Apr 1;81(7):1675-8. No abstract available.

  PMID: 8117344 BACKGROUND

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: August 1, 2002
• First Posted: August 2, 2002
• Study Start: July 30, 2002
• Study Completion: June 25, 2007
• Last Updated: July 2, 2017

Record last verified: 2007-06-25

Locations

US (1)