Recruiting

Observational Study

Sponsor:

University of Toronto

Code:

NCT01351779

Conditions

Glaucoma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Glaucoma

Study ID

NCT01351779

Start date

May, 2011

Status verified date

May, 2011

Primary completion date

May, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

Progressive glaucoma

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

Primary outcome measure

  • Intraocular pressure changes that occur during sleep and with changes in body posture [ Time Frame: 24 hours ]

Central Contacts and Locations

Central contacts

Graham Prof Trope, PhD, FRCSC

4166035317Graham.Trope@uhn.on.ca

Yvonne Prof Buys, MD, FRCSC

4166035682y.buys@utoronta.ca

Locations

Toronto Western Hospital

Recruiting

Toronto, Ontario, Canada, M5T 2S8

Contacts

Graham Prof Trope, PhD, FRCSC

4166035317raham.Trope@uhn.on.ca

Principal Investigator:

Graham E Trope, PhD, FRCSC

More Information

Sponsor

University of Toronto

Last update posted

May 11, 2011

Last verified

May, 2011

Keywords

  • Intraocular pressure
  • Contact lens sensor
  • Optic disc hemorrhage

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Toronto on 2011-05-11.