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

University of California San Diego

Status: Withdrawn

Conditions: Glaucoma

Treatments: Device: Phacoemulsification with implantation of intraocular lens (CE-IOL) SENSIMED Triggerfish

Study type: Observational

Funder types: Other

Identifiers

NCT01495299

TDCAT1

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 1 patient group

cataract patients with glaucoma

Treatment:

Device: Phacoemulsification with implantation of intraocular lens (CE-IOL) SENSIMED Triggerfish