Patients With Systemic Inflammatory Diseases Receiving for the First Time a Protracted General Corticostroid TherapyNCT00337623
Impact of Systemic Corticosteroid Therapy on Lens Transparency and Quantification of Lens Autofluorescence.
A study testing Prednisolone in people with Patients With Systemic Inflammatory Diseases Receiving for the First Time a Protracted General Corticostroid Therapy, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Patients With Systemic Inflammatory Diseases Receiving for the First Time a Protracted General Corticostroid Therapy
- What is being tested?
- Prednisolone
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2000to Jul 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Clermont-Ferrand University Hospital
Clermont-Ferrand, Auvergne, 63003
About this study
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.
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.
Read the 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.
- Being tested
- Prednisolone
- Keywords
- Cataracts, Corticosteroids, Scheimpflug, Lens autofluorescence
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoloneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Cataracts on Ophthalmologist's Examination
Increase of Lens Autofluorescence
Increase of Lens Density on Scheimpflug Photography
Secondary outcomes (2)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2006 (estimated)
- Study startJun 2000
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Systemic Inflammatory Diseases Receiving for the First Time a Protracted General Corticostroid TherapyStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Investigators
- Marc Andre, Doctor, Principal investigator, University Hospital, Clermont-FerrandOlivier Aumaitre, Doctor, Principal investigator, Hopital Gabriel Montpied (Clermont-Ferrand)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00337623
- Sponsor's protocol ID
- CHU63-0011
- Status last verified
- Jun 2006
- First submitted
- 1 Jun 2006
- Last updated
- 23 Jun 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00337623
- Acronym / sponsor ID
- CHU63-0011
- Keywords
- Cataracts, Corticosteroids, Scheimpflug, Lens autofluorescence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Jun 2000
- Study completion
- Jul 2006
- First posted
- 16 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prednisolone | Drug | – |
Primary outcome
Cataracts on Ophthalmologist's Examination
Increase of Lens Autofluorescence
Increase of Lens Density on Scheimpflug Photography
2 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2006.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Andre, Doctor principal investigator
University Hospital, Clermont-Ferrand
Olivier Aumaitre, Doctor principal investigator
Hopital Gabriel Montpied (Clermont-Ferrand)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prednisolone in people with Patients With Systemic Inflammatory Diseases Receiving for the First Time a Protracted General Corticostroid Therapy, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cataracts on Ophthalmologist's Examination. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2006.