Protocol Number: 02-EI-0255

Title:

Prevalence and Risks for Posterior Subcapsular Cataracts in Volunteer Granulocytapheresis Donors

Number:

02-EI-0255

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

Sponsoring Institute:

National Eye Institute (NEI)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria:

INCLUSION CRITERIA:

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.

EXCLUSION CRITERIA:

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.

Special Instructions: Currently Not Provided

Keywords:

Cataracts

Granulocytapheresis

Granulocyte Donors

Recruitment Keywords:

Cataracts

Granulocyte Donors

Conditions:

Apheresis

Investigational Drug(s):

None

Investigational Device(s):

None

Contacts:

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:

Fryer JP, Granger DK, Leventhal JR, Gillingham K, Najarian JS, Matas AJ Steroid-related complications in the cyclosporine eraClin Transplant 1994 Jun;8(3 Pt 1):224-9 PMID: 8061360

Ghodsi Z, Strauss RG Cataracts in neutrophil donors stimulated with adrenal corticosteroidsTransfusion 2001 Dec;41(12):1464-8PMID: 11778057

Strauss RG Therapeutic granulocyte transfusions in 1993 Blood 1993 Apr 1;81(7):1675-8 Review No abstract available PMID: 8117344

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