Ocular Pressure in Steroid-treated Dermatology Patients

Terminated

• Conditions: Topical Corticosteroid-treated Dermatology Patients; Intra-ocular Pressure
• Interventions: Drug: Potent topical steroid; Drug: Superpotent topical steroid

• Registration Number: NCT01759914
• Lead Sponsor: University Hospitals Coventry and Warwickshire NHS Trust

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-12-30
• Study First Submitted QC: 2013-01-02
• Study First Posted: 2013-01-03
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-06
• Last Update Posted: 2014-03-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Potent topical steroid-treated	Potent topical steroid	Patients treated with potent topical steroids
Superpotent topical steroid-treated	Superpotent topical steroid	Patients treated with superpotent topical steroids

Primary Outcome Measures

Name	Time	Method
Change in intraocular pressure from baseline	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

Name	Time	Method
Whether there is any clinical evidence of cataract at the final visit of the study.	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.

Trial Locations

Locations (1)

University Hospitals Coventry and Warwickshire NHS Trust; 🇬🇧 Coventry, West Midlands, United Kingdom