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

NCT ID: NCT00337623

Last Updated: 2006-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-06-30

Study Completion Date

2006-07-31

Brief Summary

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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

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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.

Conditions

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

Keywords

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Cataracts Corticosteroids Scheimpflug Lens autofluorescence

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Prednisolone

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Principal Investigators

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Marc Andre, Doctor

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Olivier Aumaitre, Doctor

Role: PRINCIPAL_INVESTIGATOR

Hopital Gabriel Montpied (Clermont-Ferrand)

Locations

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Clermont-Ferrand University Hospital

Clermont-Ferrand, Auvergne, France

Site Status

Countries

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France

Other Identifiers

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CHU63-0011

Identifier Type: -

Identifier Source: org_study_id