Ocular Pressure in Steroid-treated Dermatology Patients

NCT01759914 | Terminated

• 1 other identifier: YM076710
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Topical Corticosteroid-treated Dermatology Patients; Intra-ocular Pressure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Whether there is any clinical evidence of cataract at the final visit of the study.

  After 1, 2 and 3 months

Study Arms (2)

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

Interventions

Potent topical steroid DRUG

Potent topical steroid-treated

Superpotent topical steroid DRUG

Superpotent topical steroid-treated

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Dermatology clinic

You may qualify if:

• patients on whom corticosteroid treatment is being introduced for a duration of at least 12 weeks

You may not qualify if:

• pregnant women
• patients already under glaucoma treatment
• patients unable to give informed written consent or those unable to cooperate fully with the assessments

Sponsors & Collaborators

• University Hospitals Coventry and Warwickshire NHS Trust: lead
• University Hospital, Geneva: collaborator

Study Sites (1)

University Hospitals Coventry and Warwickshire NHS Trust

Coventry, West Midlands, CV2 2DX, United Kingdom

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Registrar in Dermatology

Study Record Dates

• First Submitted: December 30, 2012
• First Posted: January 3, 2013
• Study Start: September 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: March 7, 2014

Record last verified: 2014-03

Locations

GB (1)