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

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ClinicalTrials.gov Identifier: NCT01495312
Recruitment Status : Unknown
Verified December 2011 by Cheryl Goodness, University of California, San Diego.
Recruitment status was:  Recruiting
First Posted : December 20, 2011
Last Update Posted : December 20, 2011
Sponsor:
Information provided by (Responsible Party):
Cheryl Goodness, University of California, San Diego

Brief Summary:
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 or disease Intervention/treatment Phase
Glaucoma Device: SLT (selective laser trabeculoplasty ) SENSIMED Triggerfish Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : December 2011
Estimated Primary Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Experimental: SLT Device: SLT (selective laser trabeculoplasty ) SENSIMED Triggerfish
SLT (single session; 180 to 360 degrees of angle will be treated)




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


Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01495312


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

Locations
United States, California
UCSD Recruiting
La Jolla, California, United States, 92037
Contact: Kaweh Mansouri, MD       kamansouri@ucsd.edu   
UCSD Recruiting
La Jolla, California, United States, 92037
Contact: Felipe Medeiros, MD       fmedeiros@glaucoma.ucsd.edu   
UCSD Recruiting
La Jolla, California, United States
Contact: Felipe Medeiros, MD       fmedeiros@glaucoma.ucsd.edu   
UCSD Recruiting
La Jolla, California, United States
Contact: Felipe Medeiros       fmedeiros@glaucoma.ucsd.edu   
Sponsors and Collaborators
University of California, San Diego

Responsible Party: Cheryl Goodness, Research Associate, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01495312     History of Changes
Other Study ID Numbers: TFSLT1
First Posted: December 20, 2011    Key Record Dates
Last Update Posted: December 20, 2011
Last Verified: December 2011

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

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases