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

NCT ID: NCT01390779

Last Updated: 2014-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2012-05-31

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.

Conditions

Primary Open Angle Glaucoma; Healthy Subjects

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

SENSIMED Triggerfish

Intervention Type: DEVICE

Contact lens-based device intended to continuously record the timing of relative changes in IOP for up to 24 hours

Interventions

SENSIMED Triggerfish

Contact lens-based device intended to continuously record the timing of relative changes in IOP for up to 24 hours

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sensimed AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John HK Liu, PhD

Role: PRINCIPAL_INVESTIGATOR

UCSD

Locations

UCSD

San Diego, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 25942434 (View on PubMed)

Other Identifiers

10/09

Identifier Type: -

Identifier Source: org_study_id