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Completed

NCT Number: NCT01217853

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

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.

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Key information

Conditions

Primary Open Angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Schlosspark-Klinik, Berlin, Germany

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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
  • 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  • Absence of or withdrawn informed consent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

Treatment and study plan

SENSIMED Triggerfish

Device

Contact lens-based device for continuous intraocular pressure monitoring

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Sensimed AG

Industry

Collaborators

  • Schlossparkklinik

Registry information

Official study title

Comparison of 24-hour Continuous IOP Monitoring With a Contact Lens-based Sensor to Goldmann Applanation Tonometry

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 8, 2010
Registry last updated
Aug 3, 2011

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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