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

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:
NCT01495312
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 after selective laser trabeculoplasty (SLT) for routine treatment of glaucoma.


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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]

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)

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
  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: 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
Contact: Felipe Medeiros, MD       fmedeiros@glaucoma.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       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: NCT01495312     History of Changes
Other Study ID Numbers: TFSLT1
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:
IOP fluctuations
during two 24-hour periods

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on August 28, 2014