Clinical trial NCT01351779: The Effect of Body Posture on Intraocular Pressure in Progressive Glaucoma
Official title: The Effect of Body Posture on Intraocular Pressure in Progressive Glaucoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glaucoma
Keywords: Intraocular pressure
Contact lens sensor
Optic disc hemorrhage
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Sensimed AG
First posted: 2011-05-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Glaucoma clinic patients

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.


Eligibility 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

Primary outcomes:
measure: Intraocular pressure changes that occur during sleep and with changes in body posture
timeFrame: 24 hours
Secondary outcomes:
measure: Incidence of side effects or adverse effects that occur while subjects are wearing the contact lens device
timeFrame: 24 hours
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
References:
citation: Beltran-Agullo L, Buys YM, Jahan F, Shapiro CM, Flanagan JG, Cheng J, Trope GE. Twenty-four hour intraocular pressure monitoring with the SENSIMED Triggerfish contact lens: effect of body posture during sleep. Br J Ophthalmol. 2017 Oct;101(10):1323-1328. doi: 10.1136/bjophthalmol-2016-308710. Epub 2017 Mar 7.