The Effect of Body Posture on Intraocular Pressure in Progressive Glaucoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01351779
Recruitment Status : Unknown
Verified May 2011 by University of Toronto.
Recruitment status was:  Recruiting
First Posted : May 11, 2011
Last Update Posted : May 11, 2011
Sensimed AG
Information provided by:
University of Toronto

Brief 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.

Condition or disease

Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Body Posture on Intraocular Pressure in Progressive Glaucoma
Study Start Date : May 2011
Estimated Primary Completion Date : May 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Progressive glaucoma
Patients with primary open angle glaucoma identified to have an optic disc hemorrhage

Primary Outcome Measures :
  1. Intraocular pressure changes that occur during sleep and with changes in body posture [ Time Frame: 24 hours ]
    The intraocular pressure will be continuously monitored with a wireless contact lens sensor device over a 24 hour period

Secondary Outcome Measures :
  1. Incidence of side effects or adverse effects that occur while subjects are wearing the contact lens device [ Time Frame: 24 hours ]
    Patients will be monitored for contact lens related side effects or adverse effects that occur during the monitoring session.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Glaucoma clinic patients

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01351779

Contact: Graham Prof Trope, PhD, FRCSC 4166035317
Contact: Yvonne Prof Buys, MD, FRCSC 4166035682

Canada, Ontario
Toronto Western Hospital Recruiting
Toronto, Ontario, Canada, M5T 2S8
Contact: Graham Prof Trope, PhD, FRCSC    4166035317   
Principal Investigator: Graham E Trope, PhD, FRCSC         
Sub-Investigator: Yvonne M Buys, MD, FRCSC         
Sub-Investigator: Hussain Patel, MD         
Sub-Investigator: John Flanagan, DO, PhD         
Sub-Investigator: Colin Shapiro, MD, PhD         
Sub-Investigator: Farzana Jahan, MD         
Sponsors and Collaborators
University of Toronto
Sensimed AG

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Professor Graham Trope, University of Toronto Identifier: NCT01351779     History of Changes
Other Study ID Numbers: 10-0844-A
First Posted: May 11, 2011    Key Record Dates
Last Update Posted: May 11, 2011
Last Verified: May 2011

Keywords provided by University of Toronto:
Intraocular pressure
Contact lens sensor
Optic disc hemorrhage

Additional relevant MeSH terms:
Ocular Hypertension
Eye Diseases