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

May 9, 2011
May 9, 2011
May 2011
May 2012   (final data collection date for primary outcome measure)
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
Same as current
No Changes Posted
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.
Same as current
Not Provided
Not Provided
 
The Effect of Body Posture on Intraocular Pressure in Progressive Glaucoma
The Effect of Body Posture on Intraocular Pressure in Progressive Glaucoma

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Glaucoma clinic patients

Glaucoma
Not Provided
Progressive glaucoma
Patients with primary open angle glaucoma identified to have an optic disc hemorrhage
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
Not Provided
May 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact: Graham Prof Trope, PhD, FRCSC 4166035317 Graham.Trope@uhn.on.ca
Contact: Yvonne Prof Buys, MD, FRCSC 4166035682 y.buys@utoronta.ca
Canada
 
NCT01351779
10-0844-A
Yes
Professor Graham Trope, University of Toronto
University of Toronto
Sensimed AG
Not Provided
University of Toronto
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP