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Completed

NCT Number: NCT00337623

Impact of Systemic Corticosteroid Therapy on Lens Transparency 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.

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Key information

Conditions

Patients With Systemic Inflammatory Diseases Receiving for the First Time a Protracted General Corticostroid Therapy Cataract Eye Diseases Lens Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clermont-Ferrand University Hospital

Clermont-Ferrand, Auvergne, 63003, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prednisolone

Drug

Primary outcomes

  1. Cataracts on Ophthalmologist's Examination

  2. Increase of Lens Autofluorescence

  3. Increase of Lens Density on Scheimpflug Photography

Secondary outcomes

  1. Potential risk factor of cataracts related to the underlying disease or the individual

  2. Potential effect of time allowed from the beginning of treatment, duration and dosage of corticosteroids.

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study 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.

Important dates

Study start
2000
Study completion
2006
First posted
Jun 16, 2006
Registry last updated
Jun 23, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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