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

Primary Purpose

Glaucoma

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SLT (selective laser trabeculoplasty ) SENSIMED Triggerfish
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring IOP fluctuations, during two 24-hour periods

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCSD
  • UCSD

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SLT

Arm Description

Outcomes

Primary Outcome Measures

IOP

Secondary Outcome Measures

Full Information

First Posted
December 12, 2011
Last Updated
May 28, 2019
Sponsor
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT01495312
Brief Title
24-hr Intraocular Pressure (IOP) Patterns of Glaucoma Patients After Selective Laser Trabeculoplasty (SLT)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Due to staff departures unable to execute this study so requested closure. There were no study procedures performed & no participants enrolled.
Study Start Date
December 2011 (undefined)
Primary Completion Date
August 2012 (Anticipated)
Study Completion Date
August 12, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
IOP fluctuations, during two 24-hour periods

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SLT
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
SLT (selective laser trabeculoplasty ) SENSIMED Triggerfish
Intervention Description
SLT (single session; 180 to 360 degrees of angle will be treated)
Primary Outcome Measure Information:
Title
IOP
Time Frame
2 months after SLT

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
UCSD
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
UCSD
City
La Jolla
State/Province
California
Country
United States

12. IPD Sharing Statement

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

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