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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:
ClinicalTrials.gov Identifier:
NCT01253109
First Posted: December 3, 2010
Last Update Posted: January 24, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Private practicioner, Dr Sunaric Mégevand
Orasis, AugenZentrum Pajic
Information provided by:
Sensimed AG
  Purpose
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.

Condition Intervention
Pigmentary Dispersion Syndrome Pigmentary Glaucoma Patients Device: SENSIMED Triggerfish

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Detection of Induced IOP Fluctuations by SENSIMED Triggerfish® in Pigmentary Syndrome and Glaucoma Patients

Resource links provided by NLM:


Further study details as provided by Sensimed AG:

Primary Outcome Measures:
  • SENSIMED Triggerfish output values [ Time Frame: during 4 to 6 hours ]
    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 ]
    GAT IOP readings will be done in the other eye at regular intervals during 4 to 6 hours SENSIMED Triggerfish IOP monitoring


Estimated Enrollment: 15
Study Start Date: September 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
SENSIMED Triggerfish Device: SENSIMED Triggerfish
Contact lens-based device for continuous IOP monitoring

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with confirmed diagnosis of pigmentary dispersion syndrome or pigmentary glaucoma on both eyes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01253109


Locations
Switzerland
Private practice - Dr Sunaric Mégevand
Geneva, Switzerland, 1206
Sponsors and Collaborators
Sensimed AG
Private practicioner, Dr Sunaric Mégevand
Orasis, AugenZentrum Pajic
Investigators
Principal Investigator: Gordana Sunaric Megevand, Dr Private Practice
  More Information

Responsible Party: Jean-Marc Wismer, Sensimed AG
ClinicalTrials.gov Identifier: NCT01253109     History of Changes
Other Study ID Numbers: 09/11
First Submitted: December 2, 2010
First Posted: December 3, 2010
Last Update Posted: January 24, 2012
Last Verified: January 2012

Additional relevant MeSH terms:
Syndrome
Glaucoma
Glaucoma, Open-Angle
Disease
Pathologic Processes
Ocular Hypertension
Eye Diseases