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
Recruitment status was Recruiting
Sponsor:
University of Toronto
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
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | May 9, 2011 | ||||||||
| Last Updated Date | May 9, 2011 | ||||||||
| Start Date ICMJE | May 2011 | ||||||||
| Estimated Primary Completion Date | May 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
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. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | The Effect of Body Posture on Intraocular Pressure in Progressive Glaucoma | ||||||||
| Official Title ICMJE | The Effect of Body Posture on Intraocular Pressure in Progressive Glaucoma | ||||||||
| 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Glaucoma clinic patients |
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| Condition ICMJE | Glaucoma | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Progressive glaucoma
Patients with primary open angle glaucoma identified to have an optic disc hemorrhage |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 20 | ||||||||
| Completion Date | Not Provided | ||||||||
| Estimated Primary Completion Date | May 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 85 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Canada | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01351779 | ||||||||
| Other Study ID Numbers ICMJE | 10-0844-A | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Professor Graham Trope, University of Toronto | ||||||||
| Study Sponsor ICMJE | University of Toronto | ||||||||
| Collaborators ICMJE | Sensimed AG | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| Information Provided By | University of Toronto | ||||||||
| Verification Date | May 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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