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

December 2, 2010
January 23, 2012
September 2010
November 2011   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01253109 on ClinicalTrials.gov Archive Site
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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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Not Provided
Probability Sample

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

  • Pigmentary Dispersion Syndrome
  • Pigmentary Glaucoma Patients
Device: SENSIMED Triggerfish
Contact lens-based device for continuous IOP monitoring
SENSIMED Triggerfish
Intervention: Device: SENSIMED Triggerfish
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
15
November 2011
November 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01253109
09/11
No
Jean-Marc Wismer, Sensimed AG
Sensimed AG
  • Private practicioner, Dr Sunaric Mégevand
  • Orasis, AugenZentrum Pajic
Principal Investigator: Gordana Sunaric Megevand, Dr Private Practice
Sensimed AG
January 2012

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