Continuous Intraocular Pressure (IOP) Monitoring in Pigme... | NCT01253109

Studies
Continuous Intraocular Pressure (IOP) Monitoring in Pigmentary Dispersion Syndrome and Pigmentary Glaucoma Patients

NCT01253109

Sponsor

Sensimed AG

Status

Terminated

Last Update Posted

Jan 24, 2012Estimated

Enrollment

15Estimated

Phase

Not provided

Conditions

Pigmentary Dispersion Syndrome
Pigmentary Glaucoma Patients

Interventions

SENSIMED Triggerfish

Countries

Switzerland

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

Jan 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Law agreement between Triggerfish signal and GAT IOP during both sessions. However, an increase in the Triggerfish signal was observed during jogging phase.

Expanded Access Info

Start Date

Sep 2010

Primary Completion Date

Nov 2011Actual

Completion Date

Nov 2011Actual

First Submitted Date

Dec 2, 2010

First Submission Date that Met QC Criteria

Dec 2, 2010

First Posted Date

Dec 3, 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

Jan 23, 2012

Last Update Posted Date

Jan 24, 2012Estimated

Name	Class
Private practicioner, Dr Sunaric Mégevand	UNKNOWN
Orasis, AugenZentrum Pajic	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

This study monitors the intraocular pressure (IOP) over 4 to 6 hours using the SENSIMED Triggerfish® device and Goldmann Applanation Tonometry (GAT) in pigment dispersion syndrome and pigmentary glaucoma patients. The aim of the study is to detect SENSIMED Triggerfish® output signal peak after induced fluctuation by physical exercise or pupil dilation.

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

15Estimated

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 IOP monitoring	SENSIMED Triggerfish

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
SENSIMED Triggerfish output values	Patients will undergo 2 sessions of 4 to 6 hours SENSIMED Triggerfish continuous intraocular pressure monitoring in a selected eye, during and/or after physical exercise and pupile dilation	during 4 to 6 hours
Goldmann Applanation Tonometry values	GAT IOP readings will be done in the other eye at regular intervals during 4 to 6 hours SENSIMED Triggerfish IOP monitoring	During 4 to 6 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Confirmed diagnosis of pigmentary dispersion syndrome or pigmentary glaucoma on both eyes
IOP of ≥ 15 mmHg
18-60 years.
Patients able to jog continuously for at least 25 minutes
Phakic eyes
Patients who accept signing an informed consent approved by the Ethics Committee.

Exclusion Criteria:

Pigmentary glaucoma already treated with peripheral laser iridotomy (PLI), argon laser peripheral iridoplasty (ALPI), argon laser trabeculoplasty (ALT) and selective laser trabeculoplasty (SLT) in any eye
Patients treated with pilocarpine or other mydriatic agent within the last 4 weeks in any eye
Anti-hypertensive treatment in the 4 weeks preceding the study and throughout the study. Following signature of informed consent, anti-hypertensive treatment will be washed out for 4 weeks prior to study procedures in enrolled patients
Patients with pseudoexfoliative (PEX) syndrome or PEX glaucoma in any eye
Patients not able to understand the nature of the research
Patients under tutorship
Corneal abnormality
Subjects with contraindications for wearing contact lenses
Full frame metal glasses during SENSIMED Triggerfish® monitoring
History of other ocular surgery except uncomplicated strabismus surgery no later than 3 months prior to study procedures
Ocular inflammation or infection
History of cardiac or pulmonary disorder
Pregnancy and lactation
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

60 Years

Standard Ages

Adult

Study Population

Patients with confirmed diagnosis of pigmentary dispersion syndrome or pigmentary glaucoma on both eyes

Sampling Method

Probability Sample