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24-hr Intraocular Pressure (IOP) Patterns of Glaucoma Patients After Selective Laser Trabeculoplasty (SLT)

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:
NCT01495312
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
August 2012   (final data collection date for primary outcome measure)
IOP [ Time Frame: 2 months after SLT ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01495312 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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24-hr Intraocular Pressure (IOP) Patterns of Glaucoma Patients After Selective Laser Trabeculoplasty (SLT)
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 after selective laser trabeculoplasty (SLT) for routine treatment of glaucoma.
Not Provided
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Glaucoma
Device: SLT (selective laser trabeculoplasty ) SENSIMED Triggerfish
SLT (single session; 180 to 360 degrees of angle will be treated)
Experimental: SLT
Intervention: Device: SLT (selective laser trabeculoplasty ) 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
Not Provided
August 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects must correspond to all other inclusion criteria in order to be eligible for the investigation.

    • 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
    • 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 90 Years
No
Contact: Felipe Medeiros, MD fmedeiros@glaucoma.ucsd.edu
United States
 
NCT01495312
TFSLT1
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