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

June 22, 2006 updated by: University Hospital, Clermont-Ferrand

Corticosteroids and Cataracts : Prospective Study of the Impact of Systemic Corticosteroid Therapy on Lens Transparency Evaluated by Scheimpflug Photography and Quantification of Lens Autofluorescence.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

22

Phase

  • Not Applicable

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

  • France
    • Auvergne
      • Clermont-Ferrand, Auvergne, France, 63003
        • Clermont-Ferrand University Hospital

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 to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

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

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Cataracts on Ophthalmologist's Examination
Increase of Lens Autofluorescence
Increase of Lens Density on Scheimpflug Photography

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Investigators

  • Principal Investigator: Marc Andre, Doctor, University Hospital, Clermont-Ferrand
  • Principal Investigator: Olivier Aumaitre, Doctor, Hopital Gabriel Montpied (Clermont-Ferrand)

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

June 1, 2000

Study Completion

July 1, 2006

Study Registration Dates

First Submitted

June 1, 2006

First Submitted That Met QC Criteria

June 15, 2006

First Posted (Estimate)

June 16, 2006

Study Record Updates

Last Update Posted (Estimate)

June 23, 2006

Last Update Submitted That Met QC Criteria

June 22, 2006

Last Verified

June 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU63-0011

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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