Clinical trial NCT00337623: Impact of Systemic Corticosteroid Therapy on Lens Transparency and Quantification of Lens Autofluorescence.
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients With Systemic Inflammatory Diseases Receiving for the First Time a Protracted General Corticostroid Therapy
Keywords: Cataracts
Corticosteroids
Scheimpflug
Lens autofluorescence
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2006-06-16
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cataracts on Ophthalmologist's Examination
measure: Increase of Lens Autofluorescence
measure: Increase of Lens Density on Scheimpflug Photography
Secondary outcomes:
measure: Potential risk factor of cataracts related to the underlying disease or the individual
measure: Potential effect of time allowed from the beginning of treatment, duration and dosage of corticosteroids.
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Clermont-Ferrand University Hospital
state: Auvergne
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Marc Andre, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Hopital Gabriel Montpied (Clermont-Ferrand)
name: Olivier Aumaitre, Doctor
role: PRINCIPAL_INVESTIGATOR
References: