Ocular Pressure in Steroid-treated Dermatology Patients

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.

Study Overview

• Status: Terminated
• Conditions: Topical Corticosteroid-treated Dermatology Patients; Intra-ocular Pressure
• Intervention / Treatment: Drug: Potent topical steroid; Drug: Superpotent topical steroid

• Study Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• United Kingdom
  • West Midlands
    • Coventry, West Midlands, United Kingdom, CV2 2DX
      • University Hospitals Coventry and Warwickshire NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Dermatology clinic

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospitals Coventry and Warwickshire NHS Trust
• Collaborators: University Hospital, Geneva

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: December 30, 2012
• First Submitted That Met QC Criteria: January 2, 2013
• First Posted (Estimate): January 3, 2013

Study Record Updates

• Last Update Posted (Estimate): March 7, 2014
• Last Update Submitted That Met QC Criteria: March 6, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: YM076710