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Impact of Systemic Corticosteroid Therapy on Lens Transparency and Quantification of Lens Autofluorescence.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00337623
First Posted: June 16, 2006
Last Update Posted: June 23, 2006
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 Hospital, Clermont-Ferrand
  Purpose
Corticosteroid therapy is usually regarded as a risk factor for the development of posterior subcapsular cataracts but prospective studies on this topic and accurate assessment of this potential adverse effect are lacking. We will evaluate changes of lens transparency after administration of systemic corticosteroid therapy for at least one year with Scheimpflug photography and quantification of lens autofluorescence.

Condition Intervention
Patients With Systemic Inflammatory Diseases Receiving for the First Time a Protracted General Corticostroid Therapy Drug: Prednisolone

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Corticosteroids and Cataracts : Prospective Study of the Impact of Systemic Corticosteroid Therapy on Lens Transparency Evaluated by Scheimpflug Photography and Quantification of Lens Autofluorescence.

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • Cataracts on Ophthalmologist's Examination
  • Increase of Lens Autofluorescence
  • Increase of Lens Density on Scheimpflug Photography

Secondary Outcome Measures:
  • Potential risk factor of cataracts related to the underlying disease or the individual
  • Potential effect of time allowed from the beginning of treatment, duration and dosage of corticosteroids.

Estimated Enrollment: 22
Study Start Date: June 2000
Estimated Study Completion Date: July 2006
Detailed Description:
Corticosteroid therapy is usually regarded as a risk factor for the development of posterior subcapsular cataracts but prospective studies on this topic and accurate assessment of this potential adverse effect are lacking. We will evaluate changes of lens transparency after administration of systemic corticosteroid therapy for at least one year with Scheimpflug photography and quantification of lens autofluorescence.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patient who starts a treatment with Prednisone, Prednisolone or Methylprednisolone for an Expected time of one year at least, with normal lens autofluorescence at inclusion.

Exclusion Criteria:

  • Previous cataracts and abnormal increase of lens autofluorescence considering age
  • Previous elevation of intraocular pressure
  • Progressive inflammatory or non inflammatory ocular disease
  • Eye drop except artificial tears
  • Insulin dependent and non insulin dependent diabetes
  • Atopic dermatitis
  • Previous protracted corticosteroid therapy
  • Drugs known to be associated with an increased risk of cataract
  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): NCT00337623


Locations
France
Clermont-Ferrand University Hospital
Clermont-Ferrand, Auvergne, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Marc Andre, Doctor University Hospital, Clermont-Ferrand
Principal Investigator: Olivier Aumaitre, Doctor Hopital Gabriel Montpied (Clermont-Ferrand)
  More Information

ClinicalTrials.gov Identifier: NCT00337623     History of Changes
Other Study ID Numbers: CHU63-0011
First Submitted: June 1, 2006
First Posted: June 16, 2006
Last Update Posted: June 23, 2006
Last Verified: June 2006

Keywords provided by University Hospital, Clermont-Ferrand:
Cataracts
Corticosteroids
Scheimpflug
Lens autofluorescence

Additional relevant MeSH terms:
Prednisolone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents