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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2011 by University of California, San Diego.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Cheryl Goodness, University of California, San Diego Identifier:
First received: December 12, 2011
Last updated: December 19, 2011
Last verified: December 2011
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.

Condition Intervention
Device: SLT (selective laser trabeculoplasty ) SENSIMED Triggerfish

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

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

Primary Outcome Measures:
  • IOP [ Time Frame: 2 months after SLT ]

Estimated Enrollment: 20
Study Start Date: December 2011
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SLT Device: SLT (selective laser trabeculoplasty ) SENSIMED Triggerfish
SLT (single session; 180 to 360 degrees of angle will be treated)


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  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 identifier: NCT01495312

United States, California
La Jolla, California, United States, 92037
La Jolla, California, United States
Sponsors and Collaborators
University of California, San Diego
  More Information

Responsible Party: Cheryl Goodness, Research Associate, University of California, San Diego Identifier: NCT01495312     History of Changes
Other Study ID Numbers: TFSLT1 
Study First Received: December 12, 2011
Last Updated: December 19, 2011

Keywords provided by University of California, San Diego:
IOP fluctuations
during two 24-hour periods

Additional relevant MeSH terms:
Ocular Hypertension
Eye Diseases processed this record on February 20, 2017