The Effect of Body Posture on Intraocular Pressure in Progressive Glaucoma
1 other identifier
observational
20
1 country
1
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.
Trial Health
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participants targeted
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 9, 2011
CompletedFirst Posted
Study publicly available on registry
May 11, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedMay 11, 2011
May 1, 2011
1 year
May 9, 2011
May 9, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Intraocular pressure changes that occur during sleep and with changes in body posture
The intraocular pressure will be continuously monitored with a wireless contact lens sensor device over a 24 hour period
24 hours
Secondary Outcomes (1)
Incidence of side effects or adverse effects that occur while subjects are wearing the contact lens device
24 hours
Study Arms (1)
Progressive glaucoma
Patients with primary open angle glaucoma identified to have an optic disc hemorrhage
Eligibility Criteria
Glaucoma clinic patients
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Torontolead
- Sensimed AGcollaborator
Study Sites (1)
Toronto Western Hospital
Toronto, Ontario, M5T 2S8, Canada
Related Publications (1)
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.
PMID: 28270491DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 9, 2011
First Posted
May 11, 2011
Study Start
May 1, 2011
Primary Completion
May 1, 2012
Last Updated
May 11, 2011
Record last verified: 2011-05