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SENSIMED Triggerfish

Primary Purpose

Glaucoma

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

SENSIMED Triggerfish

Tonometer

About this trial

This is an interventional diagnostic trial for Glaucoma

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Signed informed consent for the investigation
Confirmed diagnosis of primary open angle glaucoma or normal tension glaucoma of similar degree in both eyes
Age 18-85
Stable anti-glaucomatous therapy 4 weeks before and throughout the investigation

Exclusion Criteria:

Patients not able to understand the character and individual consequences of the investigation
Patients with contraindications for silicone contact lens wear
Wear of full frame metallic glasses during SENSIMED Triggerfish® monitoring
Diagnosis of pseudoexfoliation syndrome / pseudoexfoliative glaucoma and of pigment dispersion syndrome / pigmentary glaucoma
Severe dry eye
Patients who have had ocular surgery within the last 3 months
Corneal or conjunctival abnormality or irregularity hindering correct contact lens adaptation
Allergy to corneal anaesthesia
Simultaneous participation in other clinical research

Sites / Locations

University Hospital Leuven
University Hospital Glostrup
Hospital Clínico San Carlos
Hospital Universitari i Politècnic la Fe
Inselspital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Experimental

Active Comparator

Arm Label

Study device during 3 hours

Study device during 6 hours

Study device during 9 hours

Study device during 12 hours

Study device during 15 hours

Study device during 18 hours

Study device during 21 hours

Study device during 24 hours

Tonometric assessment during 24 hours

Arm Description

Outcomes

Primary Outcome Measures

Relationship between study device signal and tonometer reading

Secondary Outcome Measures

Full Information

NCT ID

NCT01319604

First Posted

March 18, 2011

Last Updated

August 7, 2012

Sponsor

Sensimed AG

1. Study Identification

Unique Protocol Identification Number

NCT01319604

Brief Title

SENSIMED Triggerfish

Official Title

Randomized Clinical Investigation to Assess the Efficacy of SENSIMED Triggerfish Continuous IOP Monitoring

Study Type

Interventional

2. Study Status

Record Verification Date

August 2012

Overall Recruitment Status

Completed

Study Start Date

March 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

5. Study Description

Brief Summary

The purpose of the investigation is to investigate the relationship between the study device output and tonometric assessments.

Detailed Description

60 subjects will be enrolled in total. Enrolled patients will be randomized into one of 8 device groups of 6 subjects each or into the control group containing 12 subjects. Patients in the device arm will receive one session of 3-to 24-hour continuous IOP monitoring with SENSIMED Triggerfish®. SENSIMED Triggerfish® monitoring will begin at 18h ± 2 hours for all patients. SENSIMED Triggerfish® will be installed randomly on right or left eyes. During SENSIMED Triggerfish® monitoring on one eye, GAT and/or Perkins IOP measurements will be taken in the fellow eye every 3 hours. Outside this time they will receive GAT and/or IOP measurements every 3 hours in both eyes until the end of the 24-hours period. Patients in the control group will receive GAT and/or ICare PRO IOP measurements every 3 hours for 24 hours in both eyes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glaucoma

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

59 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Study device during 3 hours

Arm Type

Experimental

Arm Title

Study device during 6 hours

Arm Type

Experimental

Arm Title

Study device during 9 hours

Arm Type

Experimental

Arm Title

Study device during 12 hours

Arm Type

Experimental

Arm Title

Study device during 15 hours

Arm Type

Experimental

Arm Title

Study device during 18 hours

Arm Type

Experimental

Arm Title

Study device during 21 hours

Arm Type

Experimental

Arm Title

Study device during 24 hours

Arm Type

Experimental

Arm Title

Tonometric assessment during 24 hours

Arm Type

Active Comparator

Intervention Type

Device

Intervention Name(s)

SENSIMED Triggerfish

Intervention Description

Soft contact lens-based device for the continuous monitoring of IOP fluctuations

Intervention Type

Device

Intervention Name(s)

Tonometer

Intervention Description

Tonometric assessment of IOP

Primary Outcome Measure Information:

Title

Relationship between study device signal and tonometer reading

Time Frame

during 24 hours of study device wear

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Signed informed consent for the investigation Confirmed diagnosis of primary open angle glaucoma or normal tension glaucoma of similar degree in both eyes Age 18-85 Stable anti-glaucomatous therapy 4 weeks before and throughout the investigation Exclusion Criteria: Patients not able to understand the character and individual consequences of the investigation Patients with contraindications for silicone contact lens wear Wear of full frame metallic glasses during SENSIMED Triggerfish® monitoring Diagnosis of pseudoexfoliation syndrome / pseudoexfoliative glaucoma and of pigment dispersion syndrome / pigmentary glaucoma Severe dry eye Patients who have had ocular surgery within the last 3 months Corneal or conjunctival abnormality or irregularity hindering correct contact lens adaptation Allergy to corneal anaesthesia Simultaneous participation in other clinical research

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Milko Iliev, MD

Organizational Affiliation

University of Bern

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital Leuven

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

University Hospital Glostrup

City

Glostrup

ZIP/Postal Code

2600

Country

Denmark

Facility Name

Hospital Clínico San Carlos

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Hospital Universitari i Politècnic la Fe

City

Valencia

ZIP/Postal Code

46026

Country

Spain

Facility Name

Inselspital

City

Bern

ZIP/Postal Code

3010

Country

Switzerland

12. IPD Sharing Statement

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SENSIMED Triggerfish

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