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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by University of California, San Diego.
Recruitment status was  Recruiting
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 25, 2014