Text Size

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
  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:

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Further study details as provided by Sensimed AG:

Primary Outcome Measures:
  • 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


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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Jean-Marc Wismer, Sensimed AG
ClinicalTrials.gov Identifier: NCT01253109     History of Changes
Other Study ID Numbers: 09/11
Study First Received: December 2, 2010
Last Updated: January 23, 2012
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on May 21, 2013