GlaucomaNCT01351779
The Effect of Body Posture on Intraocular Pressure in Progressive Glaucoma
An observational study of Glaucoma, run by University of Toronto at 1 site in Canada.
Trial 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]). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Glaucoma
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- May 2011to May 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Glaucoma clinic patients
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Toronto Western Hospital
Toronto, Ontario, M5T 2S8
Graham Prof Trope, PhD, FRCSC, 4166035317, raham.Trope@uhn.on.ca
Graham E Trope, PhD, FRCSC
About this study
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
- Keywords
- Intraocular pressure, Contact lens sensor, Optic disc hemorrhage
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Progressive glaucoma | Patients with primary open angle glaucoma identified to have an optic disc hemorrhage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours
Secondary outcomes (1)
Incidence of side effects or adverse effects that occur while subjects are wearing the contact lens device
Patients will be monitored for contact lens related side effects or adverse effects that occur during the monitoring session.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2011 (estimated)
- Study startMay 2011
- Primary completionMay 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Sensimed AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01351779
- Sponsor's protocol ID
- 10-0844-A
- Status last verified
- May 2011
- First submitted
- 9 May 2011
- Last updated
- 11 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28270491
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Body Posture on Intraocular Pressure in Progressive Glaucoma
- ClinicalTrials.gov ID
- NCT01351779
- Acronym / sponsor ID
- 10-0844-A
- Conditions
- Glaucoma
- Keywords
- Intraocular pressure, Contact lens sensor, Optic disc hemorrhage
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Sensimed AG
- Study start
- May 2011
- Primary completion
- May 2012 (estimated)
- First posted
- 11 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Progressive glaucoma | – | –Patients with primary open angle glaucoma identified to have an optic disc hemorrhage |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Glaucoma clinic patients
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Intraocular pressure changes that occur during sleep and with changes in body posture
Time frame: 24 hours
The intraocular pressure will be continuously monitored with a wireless contact lens sensor device over a 24 hour period
1 secondary outcome
Incidence of side effects or adverse effects that occur while subjects are wearing the contact lens device
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2011.
- Derived from this study: PubMed 28270491Beltran-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Graham Prof Trope, PhD, FRCSC (4166035317, Graham.Trope@uhn.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular pressure changes that occur during sleep and with changes in body posture (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01351779, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2011.