Back to resultsEfficacy of 24-hour Intraocular Pressure Fluctuation Recording With the SENSIMED Triggerfish Contact Lens Sensor
Primary Purpose
Primary Open Angle Glaucoma, Healthy Subjects
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SENSIMED Triggerfish
Sponsored by
About this trial
This is an interventional diagnostic trial for Primary Open Angle Glaucoma
Eligibility Criteria
Inclusion Criteria:
- Signed informed consent for the investigation
- Diagnosis of primary open angle glaucoma (POAG), including normal tension glaucoma, or healthy subjects, including subjects with ocular hypertension for whom no evidence or suspicion of structural or functional glaucomatous damage exists
- No anti-glaucomatous drug treatment or washed-out for 4 weeks
- IOP symmetry of +/- 3 mmHg between fellow eyes
- Age 18-80 years
- Not more than 4 diopters spherical equivalent on both eyes
- Not more than 2 diopters cylinder equivalent on both eyes
Exclusion Criteria:
- Patients who have had ocular surgery within the last 3 months.
- Corneal or conjunctival abnormality hindering contact lens adaptation
- Wear of full frame metallic glasses during SENSIMED Triggerfish® monitoring
- Severe dry eye
- Secondary forms of open angle glaucoma (OAG)
- Allergy to corneal anesthetic
- Patients with contraindications for silicone contact lens wear
- Patients not able to understand the character and individual consequences of the investigation
- Simultaneous participation in other clinical research
Sites / Locations
- UCSD
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SENSIMED Triggerfish
Arm Description
All subjects enrolled in the trial were housed in a sleep laboratory for 24 hours, during which they underwent SENSIMED Triggerfish recording on one randomly selected eye.
Outcomes
Primary Outcome Measures
SENSIMED Triggerfish Efficacy
Investigate the device's capacity to detect changes in IOP from wake to sleep, defined as a significantly positive slope on the SENSIMED Triggerfish recording (obtained on one eye in each subject), based on the established phenomenon that IOP increases from waking to sleep hours. The IOP from wake to sleep was measured in the eye contralateral to that of SENSIMED Triggerfish using pneumatonomtery. Subjects were included in the primary analysis if a difference in IOP of at least 3 mmHg was detected from wake to sleep.
One subject was excluded from the analysis due to the absence of a 3-mmHg difference in IOP from wake to sleep. Two subjects were excluded since they had less than 80% of expected SENSIMED Triggerfish data. One subject was excluded from the analysis due to an invalid SENSIMED Triggerfish recording.
SENSIMED Triggerfish Efficacy
Device's ability to detect ocular pulse frequency concurrent to heart rate, defined as the number of SENSIMED Triggerfish recording intervals showing oscillation at a frequency matching that of heart rate +/- 15%. In absence of eye blinks during sleep, an oscillating pattern is recorded. The frequency of oscillation was determined by independent reviewers for selected SENSIMED Triggerfish 30-second recording intervals for which simultaneous or close to simultaneous heart rate data was recorded. Intervals for which the oscillation frequency on SENSIMED Triggerfish pattern matched heart rate +/- 15% (tolerance due to noise caused by eye and lid movements) were considered accurate. The percentage of accurate intervals was calculated and expected to be at least 75%.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01390779
Brief Title
Efficacy of 24-hour Intraocular Pressure Fluctuation Recording With the SENSIMED Triggerfish Contact Lens Sensor
Official Title
Efficacy of 24-hour Intraocular Pressure Fluctuation Recording With the SENSIMED Triggerfish Contact Lens Sensor
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sensimed AG
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objectives of this study are to assess the safety and effectiveness of the SENSIMED Triggerfish® (TF) device in continuous recording of relative fluctuation in intraocular pressure (IOP). Safety will be assessed by recording of AEs during the 24 hours of continuous TF recording.
TF efficacy will be evaluated by demonstrating TF ability to detect:
The known phenomenon of increase in IOP when moving from waking state to going to bed, as reflected in pneumotonometer measurements
Ocular Pulse frequency relative to direct measurement of Heart Rate (HR).
A screening visit and one 24-hour IOP fluctuation recording session are planned for each patient. IOP fluctuation recording sessions will be carried out in a sleep unit. An ophthalmological examination of the eyes will be done at screening and prior to and following the device recording.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open Angle Glaucoma, Healthy Subjects
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SENSIMED Triggerfish
Arm Type
Experimental
Arm Description
All subjects enrolled in the trial were housed in a sleep laboratory for 24 hours, during which they underwent SENSIMED Triggerfish recording on one randomly selected eye.
Intervention Type
Device
Intervention Name(s)
SENSIMED Triggerfish
Intervention Description
Contact lens-based device intended to continuously record the timing of relative changes in IOP for up to 24 hours
Primary Outcome Measure Information:
Title
SENSIMED Triggerfish Efficacy
Description
Investigate the device's capacity to detect changes in IOP from wake to sleep, defined as a significantly positive slope on the SENSIMED Triggerfish recording (obtained on one eye in each subject), based on the established phenomenon that IOP increases from waking to sleep hours. The IOP from wake to sleep was measured in the eye contralateral to that of SENSIMED Triggerfish using pneumatonomtery. Subjects were included in the primary analysis if a difference in IOP of at least 3 mmHg was detected from wake to sleep.
One subject was excluded from the analysis due to the absence of a 3-mmHg difference in IOP from wake to sleep. Two subjects were excluded since they had less than 80% of expected SENSIMED Triggerfish data. One subject was excluded from the analysis due to an invalid SENSIMED Triggerfish recording.
Time Frame
from 1 hour before sleep to 1 hour after sleep
Title
SENSIMED Triggerfish Efficacy
Description
Device's ability to detect ocular pulse frequency concurrent to heart rate, defined as the number of SENSIMED Triggerfish recording intervals showing oscillation at a frequency matching that of heart rate +/- 15%. In absence of eye blinks during sleep, an oscillating pattern is recorded. The frequency of oscillation was determined by independent reviewers for selected SENSIMED Triggerfish 30-second recording intervals for which simultaneous or close to simultaneous heart rate data was recorded. Intervals for which the oscillation frequency on SENSIMED Triggerfish pattern matched heart rate +/- 15% (tolerance due to noise caused by eye and lid movements) were considered accurate. The percentage of accurate intervals was calculated and expected to be at least 75%.
Time Frame
in selected 30-second SENSIMED Triggerfish recording intervals during sleep
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Signed informed consent for the investigation
Diagnosis of primary open angle glaucoma (POAG), including normal tension glaucoma, or healthy subjects, including subjects with ocular hypertension for whom no evidence or suspicion of structural or functional glaucomatous damage exists
No anti-glaucomatous drug treatment or washed-out for 4 weeks
IOP symmetry of +/- 3 mmHg between fellow eyes
Age 18-80 years
Not more than 4 diopters spherical equivalent on both eyes
Not more than 2 diopters cylinder equivalent on both eyes
Exclusion Criteria:
Patients who have had ocular surgery within the last 3 months.
Corneal or conjunctival abnormality hindering contact lens adaptation
Wear of full frame metallic glasses during SENSIMED Triggerfish® monitoring
Severe dry eye
Secondary forms of open angle glaucoma (OAG)
Allergy to corneal anesthetic
Patients with contraindications for silicone contact lens wear
Patients not able to understand the character and individual consequences of the investigation
Simultaneous participation in other clinical research
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John HK Liu, PhD
Organizational Affiliation
UCSD
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSD
City
San Diego
State/Province
California
ZIP/Postal Code
92093-0946
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25942434
Citation
Mansouri K, Weinreb RN, Liu JH. Efficacy of a contact lens sensor for monitoring 24-h intraocular pressure related patterns. PLoS One. 2015 May 5;10(5):e0125530. doi: 10.1371/journal.pone.0125530. eCollection 2015.
Results Reference
derived
Learn more about this trial
Efficacy of 24-hour Intraocular Pressure Fluctuation Recording With the SENSIMED Triggerfish Contact Lens Sensor
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