Efficacy of 24-hour Intraocular Pressure Fluctuation Recording With the SENSIMED Triggerfish Contact Lens Sensor

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:

1. The known phenomenon of increase in IOP when moving from waking state to going to bed, as reflected in pneumotonometer measurements
2. 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.

Study Overview

• Status: Completed
• Conditions: Primary Open Angle Glaucoma; Healthy Subjects
• Intervention / Treatment: Device: SENSIMED Triggerfish

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92093-0946
      • UCSD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SENSIMED Triggerfish; 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.	Device: SENSIMED Triggerfish; Contact lens-based device intended to continuously record the timing of relative changes in IOP for up to 24 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	from 1 hour before sleep to 1 hour after sleep
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%.	in selected 30-second SENSIMED Triggerfish recording intervals during sleep

Collaborators and Investigators

• Sponsor: Sensimed AG
• Investigators: Principal Investigator: John HK Liu, PhD, UCSD

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: July 7, 2011
• First Submitted That Met QC Criteria: July 8, 2011
• First Posted (Estimate): July 11, 2011

Study Record Updates

• Last Update Posted (Estimate): January 20, 2014
• Last Update Submitted That Met QC Criteria: December 3, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: 10/09

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No