Ocular Pressure in Steroid-treated Dermatology Patients

• Sponsor: University Hospitals Coventry and Warwickshire NHS Trust (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01759914
• Collaborator: University Hospital, Geneva (Other)
• Enrollment: 25
• Location: 1
• Duration (Months): 10
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Topical Corticosteroid-treated Dermatology Patients; Intra-ocular Pressure	Drug: Potent topical steroid; Drug: Superpotent topical steroid

Study Design

• Study Type: Observational
• Actual Enrollment: 25 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Intraocular Pressure in Corticosteroid-treated Dermatology Patients
• Study Start Date: Sep 1, 2012
• Actual Primary Completion Date: Jul 1, 2013
• Actual Study Completion Date: Jul 1, 2013

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yasaman Mansouri, MD, Specialist Registrar in Dermatology, University Hospitals Coventry and Warwickshire NHS Trust
• ClinicalTrials.gov Identifier: NCT01759914
• Other Study ID Numbers: YM076710
• First Posted: Jan 3, 2013
• Last Update Posted: Mar 7, 2014
• Last Verified: Mar 1, 2014

Study Results

No Results Posted as of Mar 7, 2014