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

Withdrawn

• Conditions: Glaucoma
• Interventions: Device: Phacoemulsification with implantation of intraocular lens (CE-IOL) SENSIMED Triggerfish

• Registration Number: NCT01495299
• Lead Sponsor: University of California, San Diego

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2011-12-12
• Study First Submitted QC: 2011-12-19
• Study First Posted: 2011-12-20
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-19
• Last Update Posted: 2019-08-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
cataract patients with glaucoma	Phacoemulsification with implantation of intraocular lens (CE-IOL) SENSIMED Triggerfish	-

Primary Outcome Measures

Name	Time	Method
24-h IOP patterns	24 hour

Trial Locations

Locations (1)

UCSD; 🇺🇸 La Jolla, California, United States