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

This study has been terminated.

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

Sponsor:

Collaborators:

Private practicioner, Dr Sunaric Mégevand

Orasis, AugenZentrum Pajic

Information provided by:

Sensimed AG

ClinicalTrials.gov Identifier:

NCT01253109

First received: December 2, 2010

Last updated: January 23, 2012

Last verified: January 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

December 2, 2010

Last Updated Date

January 23, 2012

Start Date ^ICMJE

September 2010

Primary Completion Date

November 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

SENSIMED Triggerfish output values [ Time Frame: during 4 to 6 hours ] [ Designated as safety issue: No ]
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
Goldmann Applanation Tonometry values [ Time Frame: During 4 to 6 hours ] [ Designated as safety issue: No ]
GAT IOP readings will be done in the other eye at regular intervals during 4 to 6 hours SENSIMED Triggerfish IOP monitoring

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01253109 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Detection of Induced IOP Fluctuations by SENSIMED Triggerfish® in Pigmentary Syndrome and Glaucoma Patients

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

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Probability Sample

Study Population

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

Condition ^ICMJE

Pigmentary Dispersion Syndrome
Pigmentary Glaucoma Patients

Intervention ^ICMJE

Device: SENSIMED Triggerfish

Contact lens-based device for continuous IOP monitoring

Study Group/Cohort (s)

SENSIMED Triggerfish

Intervention: Device: SENSIMED Triggerfish

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Estimated Enrollment ^ICMJE

Completion Date

November 2011

Primary Completion Date

November 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Switzerland

Administrative Information

NCT Number ^ICMJE

NCT01253109

Other Study ID Numbers ^ICMJE

09/11

Has Data Monitoring Committee

Responsible Party

Jean-Marc Wismer, Sensimed AG

Study Sponsor ^ICMJE

Sensimed AG

Collaborators ^ICMJE

Private practicioner, Dr Sunaric Mégevand
Orasis, AugenZentrum Pajic

Investigators ^ICMJE

Principal Investigator:

Gordana Sunaric Megevand, Dr

Private Practice

Information Provided By

Sensimed AG

Verification Date

January 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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