24-hour IOP Fluctuation Profile Recorded With SENSIMED Triggerfish in Primary Open-angle Glaucoma (POAG) Patients After Cataract Surgery

The purpose of this study is to determine the relationship between intraocular pressure (IOP) fluctuations of glaucoma patients as recorded with an IOP-sensing contact lens (SENSIMED Triggerfish®), during two 24-hour periods, before and after cataract surgery. This device has previously been investigated and shown to be safe and well tolerated.

Inclusion Criteria:

• Subject is able to comply with the study procedures

  • 18-80 years old
  • Subjects diagnosed with glaucoma, based on presence of repeatable visual field loss and/or glaucomatous optic neuropathy based on masked review of optic disc stereophotographs and under ocular hypotensive treatment, or diagnosed with ocular hypertension, with an IOP of > 22 mmHg at the screening visit and under ocular hypotensive treatment.
  • Subject has consented to be in the trial
  • Visual acuity of 20/200 or better
  • Presence of cataract requiring phacoemulsification with lens exchange
  • Ability to understand the character and individual consequences of the study
  • For women of childbearing potential, adequate contraception

Exclusion Criteria:

• Subjects presenting with any of the following criteria will not be included in the trial:

  • Subjects with contraindications for wearing contact lenses
  • Severe dry eye syndrome
  • Keratoconus or other corneal abnormality
  • Conjunctival or intraocular inflammation
  • Eye surgery prior to and throughout the study.
  • Full frame metal glasses during SENSIMED Triggerfish® monitoring
  • Known hypersensitivity to silicone, plaster or ocular anesthesia (proparacaine)
  • Pregnancy and lactation
  • Simultaneous participation in other clinical studies