- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01128062
Canthaxanthin Retinopathy: A Long-term Observation
May 20, 2010 updated by: University of Cologne
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
35
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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NRW
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Cologne, NRW, Germany, 50937
- University Eye Hospital, University of Cologne
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with a history of oral tanning agents should report at the University Eye hospital for examination.
Description
Inclusion Criteria:
- patients using oral tanning agents for at least 2 months.
- patients of 18 years or older
Exclusion Criteria:
- none.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
2008 and 2009
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 1983
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
May 1, 2010
Study Registration Dates
First Submitted
May 20, 2010
First Submitted That Met QC Criteria
May 20, 2010
First Posted (Estimate)
May 21, 2010
Study Record Updates
Last Update Posted (Estimate)
May 21, 2010
Last Update Submitted That Met QC Criteria
May 20, 2010
Last Verified
May 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AHARMS-8310
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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