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Clinical Trials/NCT00337623
NCT00337623CompletedNot Applicable

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

University Hospital, Clermont-Ferrand1 site in 1 country22 target enrollmentStarted: June 1, 2000Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
22
Locations
1
Primary Endpoint
Cataracts on Ophthalmologist's Examination

Study Overview

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 Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
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

Outcomes

Primary Outcomes

Cataracts on Ophthalmologist's Examination

Increase of Lens Autofluorescence

Increase of Lens Density on Scheimpflug Photography

Secondary Outcomes

  • 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.

Investigators

Sponsor
University Hospital, Clermont-Ferrand
Sponsor Class
Other

Study Sites (1)

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