Status:
WITHDRAWN
24-hour IOP Fluctuation Profile Recorded With SENSIMED Triggerfish in Primary Open-angle Glaucoma (POAG) Patients After Cataract Surgery
Lead Sponsor:
University of California, San Diego
Conditions:
Glaucoma
Eligibility:
All Genders
18-80 years
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®), du...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01495299
Start Date
December 1 2011
End Date
October 1 2012
Last Update
August 21 2019
Active Locations (1)
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1
UCSD
La Jolla, California, United States