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The Effect of Body Posture on Intraocular Pressure in Progressive Glaucoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by University of Toronto.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Sensimed AG
Information provided by:
University of Toronto
ClinicalTrials.gov Identifier:
NCT01351779
First received: May 9, 2011
Last updated: NA
Last verified: May 2011
History: No changes posted
  Purpose

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
Glaucoma

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:

MedlinePlus related topics: Eye Wear Glaucoma
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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)
Groups/Cohorts
Progressive glaucoma
Patients with primary open angle glaucoma identified to have an optic disc hemorrhage

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Glaucoma clinic patients

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01351779

Contacts
Contact: Graham Prof Trope, PhD, FRCSC 4166035317 Graham.Trope@uhn.on.ca
Contact: Yvonne Prof Buys, MD, FRCSC 4166035682 y.buys@utoronta.ca

Locations
Canada, Ontario
Toronto Western Hospital Recruiting
Toronto, Ontario, Canada, M5T 2S8
Contact: Graham Prof Trope, PhD, FRCSC     4166035317     raham.Trope@uhn.on.ca    
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

No publications provided

Responsible Party: Professor Graham Trope, University of Toronto
ClinicalTrials.gov Identifier: NCT01351779     History of Changes
Other Study ID Numbers: 10-0844-A
Study First Received: May 9, 2011
Last Updated: May 9, 2011
Health Authority: Canada: University Health Network Research Ethics Board and Health Canada

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

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on May 19, 2013