Ocular Pressure in Steroid-treated Dermatology Patients

This study has been terminated.
(Unable to recruit sufficient number of subjects in required timeline.)
Sponsor:
Collaborator:
University Hospital, Geneva
Information provided by (Responsible Party):
Yasaman Mansouri, MD, University Hospitals Coventry and Warwickshire NHS Trust
ClinicalTrials.gov Identifier:
NCT01759914
First received: December 30, 2012
Last updated: March 6, 2014
Last verified: March 2014
  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

Resource links provided by NLM:


Further study details as provided by University Hospitals Coventry and Warwickshire NHS Trust:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 25
Study Start Date: September 2012
Study Completion Date: July 2013
Primary Completion Date: July 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
Study Population

Dermatology clinic

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01759914

Locations
United Kingdom
University Hospitals Coventry and Warwickshire NHS Trust
Coventry, West Midlands, United Kingdom, CV2 2DX
Sponsors and Collaborators
University Hospitals Coventry and Warwickshire NHS Trust
University Hospital, Geneva
  More Information

No publications provided

Responsible Party: Yasaman Mansouri, MD, 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: March 6, 2014
Health Authority: United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

ClinicalTrials.gov processed this record on April 15, 2014