Intraocular Pressure (IOP) Patterns in Fast Versus Slow Visual Field (VF) Progression Patients
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| ClinicalTrials.gov Identifier: NCT01828255 |
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Recruitment Status :
Terminated
(Low recruitment rate)
First Posted : April 10, 2013
Results First Posted : October 9, 2020
Last Update Posted : October 9, 2020
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Sponsor:
Sensimed AG
Information provided by (Responsible Party):
Sensimed AG
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| Tracking Information | ||||||||||
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| First Submitted Date ICMJE | April 5, 2013 | |||||||||
| First Posted Date ICMJE | April 10, 2013 | |||||||||
| Results First Submitted Date ICMJE | November 17, 2015 | |||||||||
| Results First Posted Date ICMJE | October 9, 2020 | |||||||||
| Last Update Posted Date | October 9, 2020 | |||||||||
| Study Start Date ICMJE | March 2013 | |||||||||
| Actual Primary Completion Date | May 2014 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures ICMJE |
Relationship Between 24-hour IOP Pattern as Recorded by TF and VF Progression in Patients With POAG. [ Time Frame: 24-hour ] 24-hour measurement of TF, corresponding to IOP-related fluctuations expressed in arbitrary units of mini volts equivalent (mVeq) and comparison of this measurement between POAG patients showing fast and slow rates of glaucoma visual field progression.
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| Original Primary Outcome Measures ICMJE |
Relationship Between 24-hour IOP Pattern as Recorded by TF and VF Progression in Patients With POAG. [ Time Frame: 24-hour ] Difference of the 24-hour IOP pattern as recorded by TF between patients with POAG with fast and slow rates of VF progression
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| Change History | ||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
Relationship between 24-hour IOP pattern as recorded by TF and VF progression in patients with POAG. [ Time Frame: 24-hour ] Wake-sleep slope and sleep-wake slope Diurnal and nocturnal pattern Number of peaks Relationship between the 24-hour IOP fluctuations and 24-hour blood pressure pattern
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| Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title ICMJE | Intraocular Pressure (IOP) Patterns in Fast Versus Slow Visual Field (VF) Progression Patients | |||||||||
| Official Title ICMJE | A Single Center, Case-control, Open Label Study Assessing Intraocular Pressure Patterns in Patients With Primary Open-angle Glaucoma Experiencing Fast Versus Slow Visual Field Progression | |||||||||
| Brief Summary | The purpose of this study is to investigate how the intraocular pressure (IOP) varies in time and if the IOP variations are associated with the worsening of glaucoma. IOP patterns will be recorded continuously over 24 hours with SENSIMED Triggerfish® (TF) a portable investigational device using a contact lens sensor. After completing the Triggerfish lens placement and removal; the patient will complete a formal Polysomnography. | |||||||||
| Detailed Description | Not Provided | |||||||||
| Study Type ICMJE | Interventional | |||||||||
| Study Phase ICMJE | Not Applicable | |||||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
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| Condition ICMJE | Primary Open-angle Glaucoma (POAG) Patient | |||||||||
| Intervention ICMJE | Device: SENSIMED Triggerfish® | |||||||||
| Study Arms ICMJE | Experimental: SENSIMED Triggerfish®
Device: portable device that monitors the 24-hour IOP pattern by a wireless contact lens sensor placed on the eye that sends its signals via an antenna around the orbital cavity to a recorder. Upon completion, the recording can be transmitted to a computer for read-out and visualization.
Intervention: Device: SENSIMED Triggerfish®
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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 | Terminated | |||||||||
| Actual Enrollment ICMJE |
40 | |||||||||
| Original Estimated Enrollment ICMJE |
60 | |||||||||
| Actual Study Completion Date ICMJE | May 2014 | |||||||||
| Actual Primary Completion Date | May 2014 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 40 Years to 89 Years (Adult, Older Adult) | |||||||||
| Accepts Healthy Volunteers ICMJE | No | |||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries ICMJE | United States | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number ICMJE | NCT01828255 | |||||||||
| Other Study ID Numbers ICMJE | TF-1212 | |||||||||
| Has Data Monitoring Committee | No | |||||||||
| U.S. FDA-regulated Product | Not Provided | |||||||||
| IPD Sharing Statement ICMJE | Not Provided | |||||||||
| Responsible Party | Sensimed AG | |||||||||
| Study Sponsor ICMJE | Sensimed AG | |||||||||
| Collaborators ICMJE | Not Provided | |||||||||
| Investigators ICMJE |
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| PRS Account | Sensimed AG | |||||||||
| Verification Date | September 2020 | |||||||||
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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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