Comparison of Sensimed Triggerfish With Goldmann Applanat... | NCT01391078

Studies
Comparison of Sensimed Triggerfish With Goldmann Applanation Tonometry and Perkins Tonometry

NCT01391078

Sponsor

Katrin Lorenz

Status

Completed

Last Update Posted

Nov 28, 2012Estimated

Enrollment

12Actual

Phase

Not Applicable

Conditions

Primary Open Angle Glaucoma

Interventions

Sensimed Triggerfish Sensor
Goldmann Applanation Tonometry, Perkins Tonometry

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

Nov 2012

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

Jun 2011

Primary Completion Date

Jan 2012Actual

Completion Date

Feb 2012Actual

First Submitted Date

Jun 14, 2011

First Submission Date that Met QC Criteria

Jul 7, 2011

First Posted Date

Jul 11, 2011Estimated

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

Nov 27, 2012

Last Update Posted Date

Nov 28, 2012Estimated

Name	Class
Sensimed AG	INDUSTRY

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

This prospective, crossover study is designed to correlate SENSIMED Triggerfish® (TF) continuous IOP monitoring with conventional 24 h intraocular pressure profiles in glaucoma patients. There are two control measurements: The GAT/Perkins profile in the same eye in the second night and the GAT/Perkins profile in the same night in the fellow eye. Therefore, each eye serves as test eye and also as control for the second test eye.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sensimed Triggerfish	Experimental		Device: Sensimed Triggerfish Sensor
Goldmann Applanation Tonometry/Perkins Tonometry	Active Comparator		Device: Goldmann Applanation Tonometry, Perkins Tonometry

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sensimed Triggerfish Sensor	Device	IOP will be monitored for 24 hours	Sensimed Triggerfish

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Relation of GAT/Perkins with TF in a cross-over regression analysis.	Correlation of GAT/Perkins values with TF data (mean, min, max, fluctuation)	48 hours

Secondary Outcomes

Measure	Description	Time Frame
Correlation of IOP in the test eye (TF) compared to a conventional 24h IOP profile (GAT) the reference eye (same night)	Correlation of GAT/Perkins values with TF data (mean, min, max, fluctuation)	48 hours
Correlation of IOP profile (GAT) right versus left eye

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient is able to comply with the study procedure
Patient must be ≥ 18 years old
Diagnosis of primary open angle glaucoma (EGS criteria)
Similar behaviour of IOP in both eyes in former IOP profiles
Patient has consented to be in the trial and signed informed consent is available before any study related procedures are carried out
Visual Acuity of 20/200 or better in both eyes
Ability of subject to understand the character and individual consequences of the study
For women with childbearing potential, adequate contraception

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Ophthalmology, University Medical Center, Johannes Gutenberg-University Mainz		Mainz	RLP	55131	Germany

Condition Browse Module

MeSH Terms

ID	Term
D005902	Glaucoma, Open-Angle
D005901	Glaucoma

Ancestor Terms

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided