24h Continuous Intraocular Pressure (IOP) Monitoring vs Goldmann Applanation Tonometry

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. Identifier: NCT01217853
Recruitment Status : Completed
First Posted : October 8, 2010
Last Update Posted : August 3, 2011
Information provided by:
Sensimed AG

Brief Summary:
A study in which intraocular pressure (IOP) will be monitored over 24 hours using the SENSIMED Triggerfish® device and Goldmann applanation tonometry (GAT) in primary open angle glaucoma patients. The aim of this study is to investigate the comparability of diurnal IOP patterns emerging from SENSIMED Triggerfish and GAT.

Condition or disease Intervention/treatment
Primary Open Angle Glaucoma Device: SENSIMED Triggerfish

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of 24-hour Continuous IOP Monitoring With a Contact Lens-based Sensor to Goldmann Applanation Tonometry
Study Start Date : August 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Group/Cohort Intervention/treatment
SENSIMED Triggerfish Device: SENSIMED Triggerfish
Contact lens-based device for continuous intraocular pressure monitoring

Primary Outcome Measures :
  1. SENSIMED Triggerfish output values [ Time Frame: During 24 hours ]
    Patients will undergo one session of 24-hour SENSIMED Triggerfish continuous intraocular pressure monitoring in one eye.

  2. Goldmann applanation tonometry values [ Time Frame: During 24 hours ]
    Goldmann applanation IOP readings will be done in the other eye at regular intervals during 24-hour SENSIMED Triggerfish IOP monitoring and in both eyes during another 24-hour session.

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Male or female patients 40 to 70 years old and diagnosed with primary open angle glaucoma.

Inclusion Criteria:

  • Signed informed consent for the investigation
  • Patients with primary open angle glaucoma (POAG), defined as open angle ≥ 30°, confirmed visual field loss (Mean Defect/Least Variance ≤ 2dB) and/or optic nerve head damage (cup disc ratio > 0,5)
  • Age 40-70 years at inclusion
  • Not more than 4 diopters spherical equivalent on the study eye
  • Not more than 2 diopters cylinder equivalent on the study eye
  • For women of childbearing potential, adequate contraception
  • Stable anti-glaucomatous therapy 4 weeks before the first 24-hour IOP assessment session and throughout the investigation

Exclusion Criteria:

  • Patients not able to understand the character and individual consequences of the investigation
  • Patients committed to an institution by virtue of an order issued either by the courts or by an authority
  • Absence of or withdrawn informed consent
  • Patients with contraindications for silicone contact lens wear
  • Wear of full frame metallic glasses during SENSIMED Triggerfish monitoring
  • Eye disorders including severe dry eye
  • Eye disorders secondary to POAG
  • Patient who have had ocular surgery within the last 3 months
  • Corneal or conjunctival abnormality or irregularity hindering correct contact lens adaptation
  • Pregnancy and lactation
  • Allergy to oxybuprocaine (ocular anesthesia)
  • Simultaneous participation in other clinical research

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 identifier (NCT number): NCT01217853

Berlin, Germany, 14059
Johannes Gutenberg Universitätsklinik Mainz
Mainz, Germany, 55131
Sponsors and Collaborators
Sensimed AG
Principal Investigator: Carl Erb, Prof Schlosspark-Klinik Berlin

Responsible Party: Jean-Marc Wismer, Sensimed AG Identifier: NCT01217853     History of Changes
Other Study ID Numbers: 09/10
First Posted: October 8, 2010    Key Record Dates
Last Update Posted: August 3, 2011
Last Verified: August 2011

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