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

This study has been completed.
Sponsor:
Collaborator:
Schlossparkklinik
Information provided by:
Sensimed AG
ClinicalTrials.gov Identifier:
NCT01217853
First received: October 7, 2010
Last updated: August 2, 2011
Last verified: August 2011
  Purpose

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 Intervention
Primary Open Angle Glaucoma
Device: SENSIMED Triggerfish

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Sensimed AG:

Primary Outcome Measures:
  • SENSIMED Triggerfish output values [ Time Frame: During 24 hours ] [ Designated as safety issue: No ]
    Patients will undergo one session of 24-hour SENSIMED Triggerfish continuous intraocular pressure monitoring in one eye.

  • Goldmann applanation tonometry values [ Time Frame: During 24 hours ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 30
Study Start Date: August 2010
Study Completion Date: August 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
SENSIMED Triggerfish Device: SENSIMED Triggerfish
Contact lens-based device for continuous intraocular pressure monitoring

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01217853

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

No publications provided

Responsible Party: Jean-Marc Wismer, Sensimed AG
ClinicalTrials.gov Identifier: NCT01217853     History of Changes
Other Study ID Numbers: 09/10
Study First Received: October 7, 2010
Last Updated: August 2, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on April 17, 2014