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Canthaxanthin Retinopathy: A Long-term Observation

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ClinicalTrials.gov Identifier: NCT01128062
Recruitment Status : Completed
First Posted : May 21, 2010
Last Update Posted : May 21, 2010
Sponsor:
Information provided by:
University of Cologne

Brief Summary:
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 or disease
Canthaxanthin Retinopathy

Study Type : Observational
Actual Enrollment : 35 participants
Observational Model: Case-Only
Time Perspective: Prospective
Study Start Date : December 1983
Actual Primary Completion Date : December 2009
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. 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.



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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:


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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

ClinicalTrials.gov Identifier: NCT01128062     History of Changes
Other Study ID Numbers: AHARMS-8310
First Posted: May 21, 2010    Key Record Dates
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