24h Continuous Intraocular Pressure (IOP) Monitoring vs G... | NCT01217853

Studies
24h Continuous Intraocular Pressure (IOP) Monitoring vs Goldmann Applanation Tonometry

NCT01217853

Sponsor

Sensimed AG

Status

Completed

Last Update Posted

Aug 3, 2011Estimated

Enrollment

30Estimated

Phase

Not provided

Conditions

Primary Open Angle Glaucoma

Interventions

SENSIMED Triggerfish

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2010

Primary Completion Date

Jun 2011Actual

Completion Date

Aug 2011Actual

First Submitted Date

Oct 7, 2010

First Submission Date that Met QC Criteria

Oct 7, 2010

First Posted Date

Oct 8, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 2, 2011

Last Update Posted Date

Aug 3, 2011Estimated

Name	Class
Schlossparkklinik	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A study in which intraocular pressure (IOP) will be monitored over 24 hours using the SENSIMED Triggerfish® device and Goldmann applanation tonometry (GAT) in primary open angle glaucoma patients. The aim of this study is to investigate the comparability of diurnal IOP patterns emerging from SENSIMED Triggerfish and GAT.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Label	Type	Description	Intervention Names
SENSIMED Triggerfish			Device: SENSIMED Triggerfish

Name	Type	Description	Arm Group Labels	Other Names
SENSIMED Triggerfish	Device	Contact lens-based device for continuous intraocular pressure monitoring	SENSIMED Triggerfish

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
SENSIMED Triggerfish output values	Patients will undergo one session of 24-hour SENSIMED Triggerfish continuous intraocular pressure monitoring in one eye.	During 24 hours
Goldmann applanation tonometry values	Goldmann applanation IOP readings will be done in the other eye at regular intervals during 24-hour SENSIMED Triggerfish IOP monitoring and in both eyes during another 24-hour session.	During 24 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Signed informed consent for the investigation
Patients with primary open angle glaucoma (POAG), defined as open angle ≥ 30°, confirmed visual field loss (Mean Defect/Least Variance ≤ 2dB) and/or optic nerve head damage (cup disc ratio > 0,5)
Age 40-70 years at inclusion
Not more than 4 diopters spherical equivalent on the study eye
Not more than 2 diopters cylinder equivalent on the study eye
For women of childbearing potential, adequate contraception
Stable anti-glaucomatous therapy 4 weeks before the first 24-hour IOP assessment session and throughout the investigation

Exclusion Criteria:

Patients not able to understand the character and individual consequences of the investigation
Patients committed to an institution by virtue of an order issued either by the courts or by an authority
Absence of or withdrawn informed consent
Patients with contraindications for silicone contact lens wear
Wear of full frame metallic glasses during SENSIMED Triggerfish monitoring
Eye disorders including severe dry eye
Eye disorders secondary to POAG
Patient who have had ocular surgery within the last 3 months
Corneal or conjunctival abnormality or irregularity hindering correct contact lens adaptation
Pregnancy and lactation
Allergy to oxybuprocaine (ocular anesthesia)
Simultaneous participation in other clinical research

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Male or female patients 40 to 70 years old and diagnosed with primary open angle glaucoma.

Sampling Method

Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Schlosspark-Klinik		Berlin		14059	Germany
Johannes Gutenberg Universitätsklinik Mainz

ID	Term
D005901	Glaucoma
D009798	Ocular Hypertension
D005128	Eye Diseases