Central Corneal Thickness With SENSIMED Triggerfish | NCT01210963

Studies
Central Corneal Thickness With SENSIMED Triggerfish

NCT01210963

Sponsor

Sensimed AG

Status

Completed

Last Update Posted

Mar 18, 2011Estimated

Enrollment

20Estimated

Phase

Not provided

Conditions

Glaucoma
Ocular Hypertension

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

Mar 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

Sep 2010

Primary Completion Date

Feb 2011Actual

Completion Date

Feb 2011Actual

First Submitted Date

Sep 27, 2010

First Submission Date that Met QC Criteria

Sep 28, 2010

First Posted Date

Sep 29, 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

Mar 17, 2011

Last Update Posted Date

Mar 18, 2011Estimated

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

Investigation of the occurrence of possible corneal swelling after continuous Intraocular pressure (IOP) monitoring with a contact lens-based Sensor during the sleeping period.

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

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SENSIMED Triggerfish			Device: SENSIMED Triggerfish

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SENSIMED Triggerfish	Device	Contact lens-based Sensor with recording system for continuous monitoring of IOP fluctuation	SENSIMED Triggerfish

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pachymetry (central corneal thickness)		after 8 hours nocturnal continuous IOP monitoring

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

glaucoma and ocular hypertension scheduled for overnight hospitalisation
stable IOP-lowering treatment since at least 4 weeks before study
at least 18 years
having provided informed consent

Exclusion Criteria:

contact lens wear within the last 2 years
contraindication for silicone lean wear
corneal abnormality in either eye
ocular infection or inflammation
history of ocular surgery within the last 3 months
full-frame metal glasses during IOP monitoring with SENSIMED Triggerfish
pregnancy and lactation
patients not able to understand the nature of the research
patients under tutelage
patients committed to an institution by virtue of an order issued either by the courts or by an authority
simultaneous participation in other clinical research

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

Glaucoma and ocular hypertension patients, at least 18 years old and with stable IOP-lowering treatment (if any).

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thomas Klink, PD Dr. med	Wuerzburg University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Augen- und Poliklinik, Universitätsklinikum Würzburg		Würzburg		97080	Germany

ID	Term
D005901	Glaucoma
D009798	Ocular Hypertension