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NCT00042627 · ClinicalTrials.gov registry record
Prevalence and Risk of Cataracts in Granulocyte Donors
A clinical trial, sponsored by National Eye Institute (NEI).
- Completed
- Registry status
- 252
- Enrollment target
NCT00042627 is a clinical trial that has completed, run by National Eye Institute (NEI). The registered enrollment target is 252 participants.
The verdict
NCT00042627 has completed, sponsored by National Eye Institute (NEI).
- COMPLETED
- Registry status
- 252 participants
- Enrollment target
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 an
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 252 participants |
| Start Date | 2002-07-30 |
| Est. Completion | 2007-06-25 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00042627
The ClinicalTrials.gov registry entry for NCT00042627 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 252 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Eye Institute (NEI), which has 221 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT00042627 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00042627 about?
NCT00042627 is a clinical study titled "Prevalence and Risk of Cataracts in Granulocyte Donors". 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 procedur...
What is the current status of trial NCT00042627?
This trial is currently completed. The enrollment target is 252 participants. The study started on 2002-07-30. Estimated completion is 2007-06-25.
Who is sponsoring clinical trial NCT00042627?
This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.
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