Ocular Pressure in Steroid-treated Dermatology Patients
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Topical Corticosteroid-treated Dermatology Patients Intra-ocular Pressure |
Drug: Potent topical steroid Drug: Superpotent topical steroid |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Intraocular Pressure in Corticosteroid-treated Dermatology Patients |
- Change in intraocular pressure from baseline [ Time Frame: after 1, 2 and 3 months ] [ Designated as safety issue: No ]Measurements will be done at 28 (+/- 7 days) days, 56 (+/- 7 days) days, and 90 (+/- 7 days)days after initiation of topical steroids.
- Whether there is any clinical evidence of cataract at the final visit of the study. [ Time Frame: After 1, 2 and 3 months ] [ Designated as safety issue: No ]Measurements will be done at 28 (+/- 7 days) days, 56 (+/- 7 days) days, and 90 (+/- 7 days)days after initiation of topical steroids.
| Estimated Enrollment: | 120 |
| Study Start Date: | September 2012 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Potent topical steroid-treated
Patients treated with potent topical steroids
|
Drug: Potent topical steroid |
|
Superpotent topical steroid-treated
Patients treated with superpotent topical steroids
|
Drug: Superpotent topical steroid |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Dermatology clinic
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
Contacts and Locations| Contact: Yasaman Mansouri, MD, MRCP | +442476602020 | yasaman.mansouri@heartofengland.nhs.uk |
| United Kingdom | |
| University Hospitals Coventry and Warwickshire NHS Trust | Recruiting |
| Coventry, West Midlands, United Kingdom, CV2 2DX | |
More Information
No publications provided
| Responsible Party: | Dr Yasaman Mansouri, Specialist Registrar in Dermatology, University Hospitals Coventry and Warwickshire NHS Trust |
| ClinicalTrials.gov Identifier: | NCT01759914 History of Changes |
| Other Study ID Numbers: | YM076710 |
| Study First Received: | December 30, 2012 |
| Last Updated: | January 2, 2013 |
| Health Authority: | United Kingdom: National Health Service United Kingdom: Research Ethics Committee |
ClinicalTrials.gov processed this record on June 18, 2013