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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2011-12-31

Study Completion Date

2012-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Glaucoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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cataract patients with glaucoma

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

Intervention Type DEVICE

Phacoemulsification (standard cataract extraction surgery)

Interventions

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

Phacoemulsification (standard cataract extraction surgery)

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No