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Ocular Pressure in Steroid-treated Dermatology Patients

This study has been terminated.
(Unable to recruit sufficient number of subjects in required timeline.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01759914
First Posted: January 3, 2013
Last Update Posted: March 7, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University Hospital, Geneva
Information provided by (Responsible Party):
Yasaman Mansouri, MD, University Hospitals Coventry and Warwickshire NHS Trust
  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 Yasaman Mansouri, MD, University Hospitals Coventry and Warwickshire NHS Trust:

Primary Outcome Measures:
  • Change in intraocular pressure from baseline [ Time Frame: after 1, 2 and 3 months ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: December 30, 2012
First Posted: January 3, 2013
Last Update Posted: March 7, 2014
Last Verified: March 2014