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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: Completed study, sponsored by National Eye Institute (NEI).

NCT00042627 is a clinical trial that has completed, run by National Eye Institute (NEI). The registered enrollment target is 252 participants. According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 252 participants
Start Date 2002-07-30
Est. Completion 2007-06-25
National Eye Institute (NEI)

221 total trials

What the finished NCT00042627 record still lists

NCT00042627 is an observational study that tracks outcomes without assigning an intervention. The registered 252 participants enrollment target is mid-sized for trials with a published cap.

The record links to 0 conditions, and to 0 interventions.

NCT00042627 does not publish any study locations in the registry export this page uses.

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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Source: ClinicalTrials.gov NCT00042627, the US trial registry maintained by the National Library of Medicine. NCT00042627 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.