Intra-ocular Pressure Clinical Trial
Official title:
Intraocular Pressure in Corticosteroid-treated Dermatology Patients
Ocular hypertension and glaucoma are eye conditions associated with abnormally high fluid
pressure in the eye (called intraocular pressure or IOP). If left untreated, the elevated
IOP may eventually cause damage to the nerve of the eye and potential impairment of vision.
The use of certain drugs has been identified as a risk factor for raised IOP, including
various forms of administration of corticosteroids. Corticosteroids can also lead to
cataract, which is clouding of the lens in the eye that can affect vision.
In this research study, we would like to find out whether the use of corticosteroids in our
dermatology clinic leads to raised IOP, in order to identify patients at risk and to allow
them to be more closely monitored than others. It is important to identify those patients
who have a corticosteroid-induced pressure rise early enough to prevent them from permanent
glaucomatous visual loss.
| Status | Terminated |
| Enrollment | 25 |
| Est. completion date | July 2013 |
| Est. primary completion date | July 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - patients on whom corticosteroid treatment is being introduced for a duration of at least 12 weeks Exclusion Criteria: - pregnant women - patients already under glaucoma treatment - patients unable to give informed written consent or those unable to cooperate fully with the assessments |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | University Hospitals Coventry and Warwickshire NHS Trust | Coventry | West Midlands |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospitals Coventry and Warwickshire NHS Trust | University Hospital, Geneva |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in intraocular pressure from baseline | Measurements will be done at 28 (+/- 7 days) days, 56 (+/- 7 days) days, and 90 (+/- 7 days)days after initiation of topical steroids. | after 1, 2 and 3 months | No |
| Secondary | Whether there is any clinical evidence of cataract at the final visit of the study. | Measurements will be done at 28 (+/- 7 days) days, 56 (+/- 7 days) days, and 90 (+/- 7 days)days after initiation of topical steroids. | After 1, 2 and 3 months | No |