N/A N=33 Diagnostic

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

Primary Open Angle Glaucoma · Healthy Subjects

Bottom Line

View on ClinicalTrials.gov: NCT01390779 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2014

Primary outcome: Primary: SENSIMED Triggerfish Efficacy — 56.9 mV/h

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: SENSIMED Triggerfish (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Sensimed AG
Primary completion: May 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY SENSIMED Triggerfish Efficacy	86.5	—
PRIMARY SENSIMED Triggerfish Efficacy	86.5	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01390779). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.