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Does Intravitreal Injection of Triamcinolone Acetonide Impairs the Adrenal Function

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00561236
First Posted: November 20, 2007
Last Update Posted: September 8, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
avraham ishay, HaEmek Medical Center, Israel
November 18, 2007
November 20, 2007
September 8, 2016
April 2007
December 2007   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00561236 on ClinicalTrials.gov Archive Site
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Does Intravitreal Injection of Triamcinolone Acetonide Impairs the Adrenal Function
Low Dose (1mcg ) ACTH Stimulation Test for Assessment of the Hypothalamo- Pituitary- Adrenal Axis in Patients Treated With Intravitreal Injection of Triamcinolone Acetonide
The use of intravitreal corticosteroids in the management ocular inflammatory diseases has recently gained widespread acceptance. The purpose of this study is to determine if the use of intravitreal triamcinolone is associated with suppression of endogenous cortisol production, as generally admitted for patients treated with oral or parenteral corticosteroid therapy.
The normalcy of hypothalamic- pituitary- adrenal axis (HPA axis) of enrolled subjects will will be assessed before intravitreal injection of 4mg of triamcinolone and again after one day, one week and two weeks. Patients with abnormal HPA axis will be re-tested after four weeks and later until the HPA axis function return to normal. The HPA axis will be assessed with low dose (1mcg) intravenous corticotropin(ACTH) stimulation test, in which cortisol levels will be sampled before , 30 minutes and 60 minutes after 1mcg ACTH IV injection.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample
hospital-based ophtalmologic clinic
Secondary Adrenal Insufficiency
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
January 2008
December 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients receiving intravitreous injection of triamcinolone 4mg

Exclusion Criteria:

  • patients receiving steroids in any form, except by intravitreous administration
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT00561236
002507EMC
No
Not Provided
Plan to Share IPD: No
avraham ishay, HaEmek Medical Center, Israel
HaEmek Medical Center, Israel
Not Provided
Principal Investigator: Avraham Ishay, MD Haemek Medical Center , Endocrine Institute
HaEmek Medical Center, Israel
September 2016
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