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Completed

NCT Number: NCT01319604

SENSIMED Triggerfish

The purpose of the investigation is to investigate the relationship between the study device output and tonometric assessments.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Leuven, Leuven, Belgium

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About this study

60 subjects will be enrolled in total. Enrolled patients will be randomized into one of 8 device groups of 6 subjects each or into the control group containing 12 subjects. Patients in the device arm will receive one session of 3-to 24-hour continuous IOP monitoring with SENSIMED Triggerfish®. SENSIMED Triggerfish® monitoring will begin at 18h ± 2 hours for all patients. SENSIMED Triggerfish® will be installed randomly on right or left eyes. During SENSIMED Triggerfish® monitoring on one eye, GAT and/or Perkins IOP measurements will be taken in the fellow eye every 3 hours. Outside this time they will receive GAT and/or IOP measurements every 3 hours in both eyes until the end of the 24-hours period. Patients in the control group will receive GAT and/or ICare PRO IOP measurements every 3 hours for 24 hours in both eyes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed informed consent for the investigation
  • Confirmed diagnosis of primary open angle glaucoma or normal tension glaucoma of similar degree in both eyes
  • Age 18-85
  • Stable anti-glaucomatous therapy 4 weeks before and throughout the investigation

Exclusion criteria

  • Patients not able to understand the character and individual consequences of the investigation
  • Patients with contraindications for silicone contact lens wear
  • Wear of full frame metallic glasses during SENSIMED Triggerfish® monitoring
  • Diagnosis of pseudoexfoliation syndrome / pseudoexfoliative glaucoma and of pigment dispersion syndrome / pigmentary glaucoma
  • Severe dry eye
  • Patients who have had ocular surgery within the last 3 months
  • Corneal or conjunctival abnormality or irregularity hindering correct contact lens adaptation
  • Allergy to corneal anaesthesia
  • Simultaneous participation in other clinical research

Treatment and study plan

SENSIMED Triggerfish

Device

Soft contact lens-based device for the continuous monitoring of IOP fluctuations

Tonometer

Device

Tonometric assessment of IOP

Primary outcomes

  1. Relationship between study device signal and tonometer reading

    Time frame: during 24 hours of study device wear

Sponsors and collaborators

Lead sponsor

Sensimed AG

Industry

Registry information

Official study title

Randomized Clinical Investigation to Assess the Efficacy of SENSIMED Triggerfish Continuous IOP Monitoring

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 21, 2011
Registry last updated
Aug 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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