The Effect of Body Posture on Intraocular Pressure in Progressive Glaucoma

Glaucoma Clinical Trial

Official title:

The Effect of Body Posture on Intraocular Pressure in Progressive Glaucoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01351779
• Other study ID #: 10-0844-A
• Status: Recruiting
• Phase: N/A
• First received: May 9, 2011
• Last updated: May 9, 2011
• Start date: May 2011

Study information

• Verified date: May 2011
• Source: University of Toronto
• Contact: Graham Prof Trope, PhD, FRCSC
• Phone: 4166035317
• Email: Graham.Trope[@]uhn.on.ca
• Is FDA regulated: No
• Health authority: Canada: University Health Network Research Ethics Board and Health Canada
• Study type: Observational

Clinical Trial Summary

Glaucoma is a condition where the optic nerve (the nerve responsible for sight) shows progressive damage with characteristic loss of visual field. Glaucoma is very commonly associated with raised pressure in the eye (intraocular pressure [IOP]). IOP has been shown to increase when lying down in normal subjects as well as patients with glaucoma. It is possible that this effect can make glaucoma worse. This study is designed to investigate the effect of body posture (particularly when sleeping) on the IOP fluctuation in the eye. Each patient will be required to attend for 2 separate 24 hour visits. On one visit the patient will be required to sleep flat and on the other visit at a 30° head up sleeping position. During this time the patient will be required to wear a soft contact lens (SENSIMED Triggerfish®) which has a special sensor on it that monitors the IOP continuously. The IOP measurements are wirelessly transmitted to a recorder.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• signed informed consent

• diagnosis of primary open angle glaucoma (POAG) or normal tension glaucoma (NTG) that is progressing based on recent or recurrent optic disc hemorrhage

• age 18-85 years

• not more than 4 diopters of spherical equivalent or 2 diopters of cylinder equivalent in study eye

• stable anti-glaucoma treatment for 4 weeks before first session

• for women of childbearing potential, adequate contraception

Exclusion Criteria:

• unwilling or unable to sleep in a flat or 30 degrees head up position

• ocular surgery in previous 3 months

• corneal or conjunctival abnormality

• wear of full frame metallic glasses during monitoring session

• severe dry eye

• secondary forms of glaucoma

• allergy to corneal anaesthesia

• patients with contraindications for contact lens wear

• pregnancy and lactation

• patients unable to understand the character and individual consequences of the investigation

• simultaneous participation in other research

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Glaucoma

Locations

Country	Name	City	State
Canada	Toronto Western Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of Toronto	Sensimed AG

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular pressure changes that occur during sleep and with changes in body posture	The intraocular pressure will be continuously monitored with a wireless contact lens sensor device over a 24 hour period	24 hours	No
Secondary	Incidence of side effects or adverse effects that occur while subjects are wearing the contact lens device	Patients will be monitored for contact lens related side effects or adverse effects that occur during the monitoring session.	24 hours	Yes