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

Sponsor

University Hospital, Clermont-Ferrand (Other)

Overall Status

Completed

CT.gov ID

NCT00337623

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Patients With Systemic Inflammatory Diseases Receiving for the First Time a Protracted General Corticostroid Therapy	Drug: Prednisolone	N/A

Detailed Description

Study Design

Study Type:

Interventional

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.

Study Start Date :

Jun 1, 2000

Study Completion Date :

Jul 1, 2006

Outcome Measures

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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)