Clinical trial NCT01390779: 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
Overall status: COMPLETED
Phase: NA
Conditions: Primary Open Angle Glaucoma
Healthy Subjects
Lead sponsor: Sensimed AG
Sponsor class: INDUSTRY
First posted: 2011-07-11
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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:

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.


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

Primary outcomes:
measure: SENSIMED Triggerfish Efficacy
timeFrame: from 1 hour before sleep to 1 hour after sleep
measure: SENSIMED Triggerfish Efficacy
timeFrame: in selected 30-second SENSIMED Triggerfish recording intervals during sleep
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UCSD
state: California
Study officials:
affiliation: UCSD
name: John HK Liu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.