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Canthaxanthin Retinopathy: A Long-term Observation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01128062
First Posted: May 21, 2010
Last Update Posted: May 21, 2010
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:
University of Cologne
  Purpose
Canthaxanthine is a naturally occurring carotenoid that has been a popular over-the-counter oral artificial tanning agent in Europe, Canada, and Australia since 1979. It is also used at low dosage as a food-colouring agent and as a therapeutic agent for photosensitivity disorders such as erythropoietic protoporphyria. Canthaxanthin retinopathy was first described in 1982 by Cortin et al. In Germany the office of the federal board of health refused the permit for oral tanning agents containing canthaxanthine in 1985. At that time the long-term course of the disease was not known. 25 years later the investigators did these long-term follow-up examinations.

Condition
Canthaxanthin Retinopathy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by University of Cologne:

Primary Outcome Measures:
  • all eye diseases [ Time Frame: 2008 and 2009 ]
    All patients will have the follow-up examination 2008 or 2009. The examination included at most visual acuity (distant and near vision), Amsler test, examination of anterior segment, posterior segment, 10-2 and 30-2 visual field, electrooculography, electroretinography, multifocal electroretinography, fundus photography, fluorescein angiography, and an examination for autofluorescence.


Enrollment: 35
Study Start Date: December 1983
Study Completion Date: May 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with a history of oral tanning agents should report at the University Eye hospital for examination.
Criteria

Inclusion Criteria:

  • patients using oral tanning agents for at least 2 months.
  • patients of 18 years or older

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01128062


Locations
Germany
University Eye Hospital, University of Cologne
Cologne, NRW, Germany, 50937
Sponsors and Collaborators
University of Cologne
  More Information

ClinicalTrials.gov Identifier: NCT01128062     History of Changes
Other Study ID Numbers: AHARMS-8310
First Submitted: May 20, 2010
First Posted: May 21, 2010
Last Update Posted: May 21, 2010
Last Verified: May 2010

Keywords provided by University of Cologne:
Canthaxanthin retinopathy

Additional relevant MeSH terms:
Retinal Diseases
Eye Diseases
Canthaxanthin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs