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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
  Purpose

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.


Condition Intervention
Glaucoma
 Device: Phacoemulsification with implantation of intraocular lens (CE-IOL) SENSIMED Triggerfish

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:

MedlinePlus related topics: Cataract Glaucoma
U.S. FDA Resources

Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • 24-h IOP patterns [ Time Frame: 24 hour ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: December 2011
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
cataract patients with glaucoma Device: Phacoemulsification with implantation of intraocular lens (CE-IOL) SENSIMED Triggerfish
Phacoemulsification (standard cataract extraction surgery)

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

glaucoma patients scheduled to undergo cataract surgery.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01495299

Contacts
Contact: Felipe Medeiros, MD fmedeiros@glaucoma.ucsd.edu

Locations
United States, California
UCSD Recruiting
La Jolla, California, United States
Contact: Felipe Medeiros, MD         fmedeiros@glaucoma.ucsd.edu    
Sponsors and Collaborators
University of California, San Diego
  More Information

No publications provided

Responsible Party: Cheryl Goodness, Research Associate, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01495299     History of Changes
Other Study ID Numbers: TDCAT1
Study First Received: December 12, 2011
Last Updated: December 19, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
relationship
IOP fluctuations
glaucoma
cataract surgery
SENSIMED Triggerfish

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on May 23, 2013