Text Size

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

This study is currently recruiting participants.
Verified December 2011 by University of California, San Diego
Sponsor:
Information provided by (Responsible Party):
Cheryl Goodness, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01495299
First received: December 12, 2011
Last updated: December 19, 2011
Last verified: December 2011
History of Changes

December 12, 2011
December 19, 2011
December 2011
October 2012   (final data collection date for primary outcome measure)
24-h IOP patterns [ Time Frame: 24 hour ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01495299 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
24-hour IOP Fluctuation Profile Recorded With SENSIMED Triggerfish in Primary Open-angle Glaucoma (POAG) Patients After Cataract Surgery
Not Provided

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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

glaucoma patients scheduled to undergo cataract surgery.
Glaucoma
Device: Phacoemulsification with implantation of intraocular lens (CE-IOL) SENSIMED Triggerfish
Phacoemulsification (standard cataract extraction surgery)
cataract patients with glaucoma
Intervention: Device: Phacoemulsification with implantation of intraocular lens (CE-IOL) SENSIMED Triggerfish
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
October 2012
October 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact: Felipe Medeiros, MD fmedeiros@glaucoma.ucsd.edu
United States
 
NCT01495299
TDCAT1
No
Cheryl Goodness, University of California, San Diego
University of California, San Diego
Not Provided
Not Provided
University of California, San Diego
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP