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

Withdrawn before enrolling

Conditions studied: Glaucoma

In brief

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.

Key facts

Study ID

NCT01495299

Run by

University of California, San Diego

People needed

0

Starts

2011-12-01

Expected to finish

2012-10-01

Last updated by the study team

2019-08-21

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UCSD — La Jolla, California, United States

Full record on ClinicalTrials.gov

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