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

Not Applicable

Completed

• Conditions: Patients With Systemic Inflammatory Diseases Receiving for the First Time a Protracted General Corticostroid Therapy

• Registration Number: NCT00337623
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief Summary

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.

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 Timeline

• Study Start: 2000-06
• Status Verified: 2006-06
• Study First Submitted: 2006-06-01
• Study First Submitted QC: 2006-06-15
• Study First Posted: 2006-06-16
• Last Update Submitted: 2006-06-22
• Last Update Posted: 2006-06-23
• Study Completion: 2006-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Cataracts on Ophthalmologist's Examination
Increase of Lens Autofluorescence
Increase of Lens Density on Scheimpflug Photography

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Clermont-Ferrand University Hospital; 🇫🇷 Clermont-Ferrand, Auvergne, France