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OpenTrials
Completed

NCT Number: NCT00966108

SENSIMED Triggerfish Discomfort During IOP Monitoring

Evaluation of the wearing discomfort (safety and tolerability) involved during IOP monitoring with the SENISMED Triggerfish, a sensor embedded in a telemetric contact lens

Completed

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Key information

Conditions

Safety and Tolerability of SENSIMED Triggerfish in Glaucoma Patients

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, Rhineland-Palatinate, 55131, Germany

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patient is able to comply with the study procedure
  • Patient is 18-80 years old
  • Healthy subject or glaucoma patient
  • Patient has consented to be in the trial and signed informed consent is available before any study related procedures are carried out
  • Cylinder refraction of no more than +/- 2 diopters in the study eye
  • Visual acuity of 20/80 or better in the study eye
  • Ability of subject to understand the character and individual consequences of the study
  • For women with childbearing potential, adequate contraception

Exclusion criteria

  • Subjects wearing contact lenses within the last two years
  • Subjects with contraindications for wearing contact lenses
  • History of refractive surgery
  • History of intraocular surgery in the last three months
  • Severe dry eye syndrome
  • Keratoconus or other corneal abnormalities
  • Conjunctival or intraocular inflammation
  • Pregnancy and lactation
  • Simultaneous participation in other clinical trials

Treatment and study plan

SENSIMED Triggerfish

Device

Ocular Telemetry Sensor for IOP monitoring

Primary outcomes

  1. ocular discomfort on a visual analogue scale

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Sensimed AG

Industry

Registry information

Official study title

Evaluation of SENSIMED Triggerfish for 24 Hour IOP Monitoring in Healthy Subjects and Glaucoma Patients

Acronym: 09/02

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Aug 26, 2009
Registry last updated
Feb 4, 2010

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.