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The Effect of Body Posture on Intraocular Pressure in Progressive Glaucoma

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2011 by University of Toronto.
Recruitment status was:  Recruiting
Sensimed AG
Information provided by:
University of Toronto Identifier:
First received: May 9, 2011
Last updated: NA
Last verified: May 2011
History: No changes posted
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.


Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Body Posture on Intraocular Pressure in Progressive Glaucoma

Resource links provided by NLM:

Further study details as provided by University of Toronto:

Primary Outcome Measures:
  • 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:
  • 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.

Estimated Enrollment: 20
Study Start Date: May 2011
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Progressive glaucoma
Patients with primary open angle glaucoma identified to have an optic disc hemorrhage


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
  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information

Responsible Party: Professor Graham Trope, University of Toronto Identifier: NCT01351779     History of Changes
Other Study ID Numbers: 10-0844-A
Study First Received: May 9, 2011
Last Updated: May 9, 2011

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

Additional relevant MeSH terms:
Ocular Hypertension
Eye Diseases processed this record on September 20, 2017