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

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

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.

Study Overview

• Status: Terminated
• Conditions: Pigmentary Dispersion Syndrome; Pigmentary Glaucoma Patients
• Intervention / Treatment: Device: SENSIMED Triggerfish

• Study Type: Observational
• Enrollment (Anticipated): 15

Contacts and Locations

Study Locations

• Switzerland
  • Geneva, Switzerland, 1206
    • Private practice - Dr Sunaric Mégevand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SENSIMED Triggerfish	Device: SENSIMED Triggerfish; Contact lens-based device for continuous IOP monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Sensimed AG
• Collaborators: Private practicioner, Dr Sunaric Mégevand; Orasis, AugenZentrum Pajic
• Investigators: Principal Investigator: Gordana Sunaric Megevand, Dr, Private Practice

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: December 2, 2010
• First Submitted That Met QC Criteria: December 2, 2010
• First Posted (Estimate): December 3, 2010

Study Record Updates

• Last Update Posted (Estimate): January 24, 2012
• Last Update Submitted That Met QC Criteria: January 23, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Disease; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle; Syndrome
• Other Study ID Numbers: 09/11